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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

Clinicaltrials.gov identifier NCT02185040

Recruitment Status Completed

First Posted July 9, 2014

Result First Posted March 19, 2020

Last update posted March 19, 2020

Study Description

Brief summary:

The purpose of this study is to determine whether CC-220 is effective for the treatment of skin, joint and serological manifestations of systemic lupus erythematosus.

  • Condition or Disease:Systemic Lupus Erythematosus
  • Intervention/Treatment: Drug: CC-220
    Drug: CC-220
    Drug: CC-220
    Drug: CC-220
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

The study consists of 2 parts. Part 1 is a randomized, double-blind, placebo controlled, ascending dose study to evaluate the safety and tolerability of CC-220 in SLE subjects. Subject participation in Part 1 consists of 3 phases: - Pre-treatment Screening Phase: up to 28 days prior to the first dose of the investigational product (IP) - Treatment Phase: up to 84 days - Observation Phase: 84 day post-treatment A total of approximately 40 subjects will be randomized into 4 dose groups with a 4:1 ratio of CC-220 (0.3 mg every other day [QOD], 0.3 mg everyday [QD], 0.6 mg and 0.3 mg on alternating days, and 0.6 mg QD) or matching placebo. In each dosing arm, 8 subjects will receive active drug and 2 subjects will receive placebo. The Treatment Phase will be up to 84 days in duration for all dose groups. Subjects who discontinue IP early and all subjects who complete the 84 day treatment phase will enter into the Observational Follow-up Phase for an 84 day period. A subject will be permitted to reduce their dose one time during Part 1 of the study. Part 2 is the Active Treatment Extension Phase (ATEP) which is an extension to evaluate the long-term efficacy and safety/tolerability of CC-220 in SLE subjects who completed Part 1 of the study. Subjects who complete the Treatment Phase of Part 1 of the study will be eligible to receive CC-220 in the ATEP for up to 2 years. All subjects who participate in the ATEP will receive either 0.3 mg QD or 0.6 mg and 0.3 mg QD on alternating days. Subjects who terminate the Treatment Phase of Part 1 early will not be eligible for entry into the ATEP. Subject participation consists of two phases: - Active Treatment Extension Phase: Up to 2 years - Observational Follow-up Phase: One month

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 42 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus
  • Actual Study Start Date: September 2014
  • Actual Primary Completion Date: September 2018
  • Actual Study Completion Date: September 2018
Arms and interventions
Arm Intervention/treatment
Experimental: CC-220 0.3mg Every Other Day (QOD)
Part 1: CC-220 0.3mg capsules by mouth every other day (QOD)
Drug: CC-220
0.3 mg oral capsules once every other day with or without food
Experimental: CC-220 0.3mg Every Day (QD)
Part 1: CC-220 0.3mg capsules by mouth every day (QD) ATEP: CC-220 0.3 mg capsules by mouth every day (QD)
Drug: CC-220
Subjects will receive 0.3 mg oral capsules every day with or without food
Experimental: CC-220 0.6mg/0.3mg alternating dose QD
Part 1: CC-220 0.6 mg and 0.3mg capsules PO on alternating days ATEP:CC-220 0.6 mg and 0.3 mg capsules PO on alternating days
Drug: CC-220
CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food
Experimental: CC-220 0.6mg QD
Part 1: CC-220 0.6mg capsules by mouth QD
Drug: CC-220
CC-220 oral capsule 0.6 mg QD with or without food
Placebo Comparator: Placebo QD
Part 1: Identically matching placebo capsules PO QD
Drug: Placebo
Matching oral placebo daily
Outcome Measures
  • Primary Outcome Measures: 1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase [ Time Frame: From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts. ]
    A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
  • 2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase [ Time Frame: From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts. ]
    A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
  • Secondary Outcome Measures: 1. Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide [ Time Frame: Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. ]
    The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
  • 2. Maximum Observed Concentration (Cmax) Of Iberdomide [ Time Frame: Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. ]
    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
  • 3. Time to Reach Maximum Concentration (Tmax) of Iberdomide [ Time Frame: Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. ]
    Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
  • 4. Terminal Phase Half-Life (T1/2) Of Iberdomide [ Time Frame: Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. ]
    Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
  • 5. Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
  • 6. Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
  • 7. Change From Baseline in Swollen Joint Count During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
  • 8. Change From Baseline in Tender Joint Count During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
  • 9. Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
  • 10. Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none 1 = mild disease 2 = moderate disease 3 = severe disease
  • 11. Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
  • 12. Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
  • 13. Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
  • 14. Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
  • 15. Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point [ Time Frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. ]
    SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Part 1

- The subject has an established diagnosis of systemic lupus erythematosus (SLE) as
defined by the 1997 Update of the 1982 ACR Revised Criteria for Classification of SLE
at screening. The diagnosis is fulfilled provided that at least 4 criteria are met.

- Disease history of SLE ≥ 6 months at baseline

- Females of childbearing potential (FCBP) must:

- Have two negative pregnancy tests as verified by the study doctor prior to
starting study therapy. She must agree to ongoing pregnancy testing during the
course of the study, and after end of study therapy. This applies even if the
subject practices true abstinence from heterosexual contact.

- Either commit to true abstinence from heterosexual contact (which must be
reviewed on a monthly basis) or agree to use, and be able to comply with,
effective contraception without interruption, 28 days prior to starting IP,
during the study therapy (including dose interruptions), and for 28 days after
discontinuation of study therapy.

- Male subjects must:

- Must practice true abstinence or agree to use a condom during sexual contact with
a pregnant female or a female of childbearing potential while participating in
the study, during dose interruptions and for at least 28 days following IP
discontinuation, even if he has undergone a successful vasectomy.

- If the subject is using oral corticosteroids, the daily dose must be less than or
equal to 10 mg of prednisone or equivalent during the study; the dose must be
stable over the 4 weeks preceding screening and throughout the study.

- All subjects taking hydroxychloroquine, chloroquine and/or quinacrine during the
study must have documentation of a normal ophthalmologic examination performed
within 1 year of the Baseline Visit.

- For subjects not taking corticosteroids, or antimalarials, the last dose (in case
of previous use) must be at least 4 weeks prior to screening.

ATEP

- Male or female 18 years of age or older

- Understand and voluntarily sign an ICD prior to the initiation of any study related
assessments/procedures

- Able to adhere to the study visit schedule and other protocol requirements. Pregnancy

- Females of childbearing potential (FCBP) must:

- Have two negative pregnancy tests as verified by the study doctor prior to
starting study therapy. She must agree to ongoing pregnancy testing during the
course of the study, and after end of study therapy. This applies even if the
subject practices true abstinence* from heterosexual contact.

- Either commit to true abstinence* from heterosexual contact (which must be
reviewed on a monthly basis) or agree to use, and be able to comply with,
effective contraception without interruption, 28 days prior to starting IP,
during the study therapy (including dose interruptions), and for 28 days after
discontinuation of study therapy.

- Male subjects must:

- Practice true abstinence or agree to use a condom during sexual contact with a
pregnant female or a female of childbearing potential while participating in the
study, during dose interruptions and for at least 28 days following IP
discontinuation, even if he has undergone a successful vasectomy. True abstinence is
acceptable when this is in line with the preferred and usual lifestyle of the subject.
(Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods]
and withdrawal are not acceptable methods of contraception.)

- Male subjects must agree not to donate semen or sperm during therapy and for at least
90 days following the discontinuation of IP.

- All subjects must:

- Understand that the IP could have potential teratogenic risk

- Agree to abstain from donating blood while taking IP and for 28 days following
discontinuation of the IP

- Agree not to share IP with another person

- Other than the subject, FCBP and males able to father a child should not handle
the IP or touch the capsules unless gloves are worn

- Be counseled about pregnancy precautions and risks of fetal exposure as described
in the Pregnancy Prevention Plan. Concomitant Medications

- If the subject is using oral corticosteroids, the daily dose must be less than or
equal to 10 mg of prednisone or equivalent during the study; the dose must be stable
over the 4 weeks preceding randomization and throughout the study.

- All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study
must have documentation of a normal ophthalmologic examination performed within 1 year
of the Baseline Visit.

- For subjects not taking corticosteroids the last dose (in case of previous use) must
be at least 4 weeks prior to screening.

Exclusion Criteria

- The subject has been treated with intra-articular, intramuscular or IV pulse
corticosteroids within 4 weeks of screening.

- The subject has received high dose oral prednisone (> 100 mg/day) within 4 weeks of
screening.

- The subject has received cyclophosphamide, azathioprine or mycophenolate mofetil
within 12 weeks of screening.

- The subject has participated in a clinical trial and has received an investigational
product within 30 days, 5 pharmacokinetic half-lives or twice the duration of the
biological effect of the investigational product (whichever is longer) prior to
screening; OR participation in two or more investigational drug trials within 12
months of screening.

- Unstable lupus nephritis defined as: proteinuria > 1.0 g/24 hour /1.73 m2 OR eGFR of
less than 60 mL/1.73 m2 CNS disease, including active severe CNS lupus (including
seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA),
cerebritis or CNS vasculitis) requiring therapeutic intervention within 6 months of
screening.

- The subject has New York Heart Association (NYHA) Class III or IV congestive heart
failure.

- Presence of hepatitis B surface antigen (HBsAG). Subjects may have a positive
anti-hepatitis B core antibody (anti-HBc) if the anti-hepatitis B surface antibody
(anti-HBs) is positive as well.

- Antibodies to hepatitis C at Screening.

- The subject has a known positive history of antibodies to human immunodeficiency virus
(HIV) or HIV disease or acquired immune deficiency syndrome (AIDs).

- Has a history of an organ transplant (e.g., heart, lung, kidney, liver) or
hematopoietic stem cell/marrow transplant.

- Malignancy or history of malignancy, except for:

- treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;

- treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ
of the cervix with no evidence of recurrence within 5 years of Screening

- Systemic bacterial infections requiring treatment with oral or injectable antibiotics,
or significant viral or fungal infections, within 4 weeks of Screening. Any treatment
for such infections must have been completed and the infection cured, at least 2 weeks
prior to Screening and no new or recurrent infections prior to the Baseline visit.

- History of venous thrombosis or any thromboembolic events within 2 years of screening.

- Clinical evidence of significant unstable or uncontrolled acute or chronic disease not
due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic,
renal, neurological, malignancy, psychiatric or infectious disease) which in the
opinion of the investigator could put the subject at undue risk or confound study
results.

- Presence of active uveitis or any other clinically significant ophthalmological
finding.

- History or current diagnosis of peripheral or radicular neuropathy. Any clinically
significant abnormalities on ECG, which, in the opinion of the investigator would
interfere with safe participation in the study.

Contacts and Locations
Contacts
Locations
Show 35 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Shimon Korish, M.D. Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02185040 History of Changes
  • Other Study ID Numbers: CC-220-SLE-001
  • First Posted: July 9, 2014 Key Record Dates
  • Last Update Posted: March 19, 2020
  • Last Verified: March 2020
  • Keywords provided by Celgene: Lupus, Systemic Lupus, SLE
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic
  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Quadruple;Primary Purpose: Treatment
  • Condition: Systemic Lupus Erythematosus
  • Interventions : Drug: CC-220
    Drug: CC-220
    Drug: CC-220
    Drug: CC-220
    Drug: Placebo
  • Enrollment: 42
Participant flow
Recruitment Details The multi-center study was conducted in the United States. Forty-two participants were enrolled at 11 study sites.
Pre-assignment Details In part 1 of the study, participants were randomly assigned to 1 of 4 dose cohorts; within each cohort participants were randomized in a 4:1 ratio to receive iberdomide or placebo. Participants who completed the Part 1 treatment phase were eligible to receive iberdomide for up to 2 years in the active treatment extension phase (ATEP).
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT Days ATEP: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg QD Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.3 mg QOD Part 1: Placebo
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP. Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years. Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase. Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase. Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase. Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase. Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
Period Title: Active Treatment Extension Phase
Started 8 9 0 0 0 0 0
Completed 1 6 0 0 0 0 0
Not Completed 7 3 0 0 0 0 0
Reason Not Completed
Lost to Follow-up 2 1
Withdrawal by Subject 1 1 1
Adverse Event 4 1 3 2 1
Miscellaneous 1 1
Period Title: Part 1 Treatment Phase
Baseline Characteristics
Arm/Group title TotalPart 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/0.3 mg ALT DaysPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QODPart 1: Placebo
Arm/Group Description Total of all reporting groupsParticipants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg capsules on alternating (ALT) days with 0.3 mg iberdomide capsules on alternating days up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days during the ATEP up to 2 years.Participants received 0.3 mg iberdomide capsules QD up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules QD during ATEP up to 2 years.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
Overall Number of Baseline Participants 4299888
Baseline Analysis Population Description [Not Specified]
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of Measure: Participants Number Analyzed 42 Participants9 Participants9 Participants8 Participants8 Participants8 Participants
Unknown or Not Reported 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%)
Not Hispanic or Latino 35 (83.33%) 8 (88.89%) 8 (88.89%) 7 (87.50%) 7 (87.50%) 5 (62.50%)
Hispanic or Latino 7 (16.67%) 1 (11.11%) 1 (11.11%) 1 (12.50%) 1 (12.50%) 3 (37.50%)
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of Measure: Participants Number Analyzed 42 Participants9 Participants9 Participants8 Participants8 Participants8 Participants
Native Hawaiian or Other Pacific Islander 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%)
American Indian or Alaska Native 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%)
Other 1 (2.38%) 0 (0.00%) 1 (11.11%) 0 (0.00%) 0 (0.00%) 0 (0.00%)
White 27 (64.29%) 5 (55.56%) 7 (77.78%) 4 (50.00%) 6 (75.00%) 5 (62.50%)
Black or African American 13 (30.95%) 4 (44.44%) 1 (11.11%) 4 (50.00%) 2 (25.00%) 2 (25.00%)
Asian 1 (2.38%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 1 (12.50%)
Sex: Female, Male Measure Type: Count of Participants Unit of Measure: Participants Number Analyzed 42 Participants9 Participants9 Participants8 Participants8 Participants8 Participants
Male 3 (7.14%) 0 (0.00%) 1 (11.11%) 1 (12.50%) 0 (0.00%) 1 (12.50%)
Female 39 (92.86%) 9 (100.00%) 8 (88.89%) 7 (87.50%) 8 (100.00%) 7 (87.50%)
Outcome Measures
1. PrimaryOutcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase
Description A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE Leading to Death

Any TEAE Leading to IP Withdrawal 4
1
Any TEAE Leading to IP Interruption 5
2
Any Serious IP-related TEAE

Any Serious TEAE 4

Any Severe TEAE 5

Any IP-related TEAE 5
2
Any TEAE 7
9
2. PrimaryOutcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase
Description A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.
Outcome Measure Data
Analysis Population Description
The safety population included all participants who were randomized and received at least 1 dose of IP. For all participants, this was the treatment group to which they were randomized.
 
Arm/Group title Part 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/0.3 mg ALT DaysPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QODPart 1: Placebo
Arm/Group Description Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
Overall Number of Participants Analyzed 99888
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE Leading to Death




Any TEAE Leading to IP Withdrawal 3
2


1
Any TEAE Leading to IP Interruption 5
1
1


Any Serious IP-related TEAE 1




Any Serious TEAE 1
1


2
Any Severe TEAE 2
1


1
Any IP-related TEAE 6
4
2
2
1
Any TEAE 8
8
7
7
5
3. SecondaryOutcome
Title Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point
Description SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Follow-Up Week 100 0.0
0.6
Week 96 0.0
0.0
Week 84 0.0
0.0
Week 72 0.0
0.0
Week 60 -0.2
0.0
Week 48 -0.2
0.0
Week 36 -0.2
0.0
Week 24 -0.2
-0.1
Week 12 -0.1
-0.1
Week 4 -0.1
-0.1
Week 1 0.0
-0.1
4. SecondaryOutcome
Title Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point
Description The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Follow-Up Week 100 0.0
-0.3
Week 96 0.0
0.0
Week 84 -1.0
0.7
Week 72 -0.7
0.3
Week 60 -2.6
0.4
Week 48 -2.4
0.3
Week 36 -2.2
0.1
Week 24 -2.2
0.1
Week 12 -0.9
-0.6
Week 4 -1.0
0.0
Week 1 0.0
-0.1
5. SecondaryOutcome
Title Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point
Description The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 60 -12.6
-22.8
Week 84 -14.0
-9.8
Week 96 -20.0
-10.3
Week 72 -25.7
-23.0
Week 48 -12.8
-29.9
Week 36 -17.2
-21.1
Week 24 -4.0
-13.6
Week 12 -8.0
-15.9
Week 4 -3.7
-4.1
Week 1 -4.0
-10.0
6. SecondaryOutcome
Title Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt
Description The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Follow-Up Week 100 0.2
-0.6
Week 96 0.0
-0.2
Week 84 0.0
0.2
Week 72 0.0
0.2
Week 60 1.1
-1.1
Week 48 0.9
-1.4
Week 36 0.7
-0.7
Week 24 0.6
-1.0
Week 12 1.3
-1.1
Week 4 0.9
-0.8
Week 1 0.8
-1.0
7. SecondaryOutcome
Title Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point
Description The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Follow-Up Week 100 -3.9
-6.3
Week 96 -0.20
-0.52
Week 84 -1.0
-7.8
Week 72 4.3
-7.5
Week 60 0.4
-6.3
Week 48 1.4
-6.1
Global Score Week 36 1.6
-7.3
Week 24 3.0
-6.3
Week 12 2.0
-2.2
Week 4 0.7
2.0
Week 1 3.3
-0.5
8. SecondaryOutcome
Title Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point
Description The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none 1 = mild disease 2 = moderate disease 3 = severe disease
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 36 -0.36
-0.57
Week 72 -0.23
-0.30
Week 60 -0.24
-0.48
Follow-Up Week 100 0.10
-0.37
Week 96 -0.20
-0.21
Week 84 -0.30
-0.52
Week 48 -0.26
-0.53
Week 24 -0.20
-0.28
Week 12 -0.31
-0.15
Week 4 -0.17
-0.26
Week 1 -0.10
-0.08
9. SecondaryOutcome
Title Maximum Observed Concentration (Cmax) Of Iberdomide
Description Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Outcome Measure Data
Analysis Population Description
The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
 
Arm/Group title Part 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/0.3 mg ALT DaysPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QOD
Arm/Group Description Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 4533
Measure Type: Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 29 3.51
2.37
1.09
1.02
Day 1 2.35
2.92
0.64
0.90
10. SecondaryOutcome
Title Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point
Description The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Percent Change
Follow-Up Week 100 -18.82
-53.04
Week 96 -26.32
-75.38
Week 84 -32.46
-65.71
Week 72 -40.35
-55.13
Week 60 -47.51
-65.64
Week 48 -46.00
-46.97
Week 36 -43.98
-0.56
Week 24 -44.69
13.54
Week 12 -36.46
-18.42
Week 4 -18.32
-32.13
Week 1 -13.35
-21.40
11. SecondaryOutcome
Title Change From Baseline in Tender Joint Count During the ATEP by Time Point
Description Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Joints
Week 72 -6.7
-5.9
Week 60 -4.4
-6.2
Week 48 -3.0
-5.6
Week 100 Follow-Up -1.4
-4.1
Week 96 0.0
-7.0
Week 84 0.0
-7.3
Week 36 -3.8
-5.1
Week 24 -3.6
-3.9
Week 12 -3.7
0.5
Week 4 -2.0
-0.9
Week 1 -2.5
-0.9
12. SecondaryOutcome
Title Change From Baseline in Swollen Joint Count During the ATEP by Time Point
Description Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Joints
Week 1 -0.4
-3.6
Week 100 Follow-Up -0.4
-3.7
Week 96 0.0
-4.2
Week 84 0.0
-4.0
Week 72 0.7
-2.6
Week 60 0.4
-3.6
Week 48 0.6
-3.9
Week 36 -0.2
-2.1
Week 24 1.2
-2.6
Week 12 -0.3
-1.8
Week 4 -0.6
-1.2
13. SecondaryOutcome
Title Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point
Description The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 100 Follow-Up 0.3
-1.7
Week 96 0.0
-2.0
Week 84 -1.0
-3.0
Week 72 -1.3
-3.0
Week 60 -1.8
-2.6
Week 48 -1.0
-2.9
Week 36 0.3
-3.1
Week 24 -1.2
-2.8
Week 12 -0.9
-1.8
Week 4 -1.7
0.2
Week 1 -1.0
0.2
14. SecondaryOutcome
Title Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point
Description The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Outcome Measure Data
Analysis Population Description
The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP. The number analyzed at each time point includes participants with a baseline value >= 4 and non-missing post-baseline value.
 
Arm/Group title ATEP: Iberdomide 0.6 mg/0.3 mg ALT DaysATEP: Iberdomide 0.3 mg QD
Arm/Group Description Participants originally assigned to the iberdomide 0.6 mg capsules QD or 0.6 mg iberdomide capsules alternating with 0.3 mg iberdomide capsules or placebo QD cohorts, (in these perspective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules on alternating days with 0.6 mg capsules when entered into the active treatment extension phase and continued for up to 2 years. Participants who were initially assigned to 0.6 mg iberdomide QD in Part 1 treatment phase, were assigned to 0.6 mg iberdomide QD up to protocol amendment 5 when the dose was reduced. Participants who received 0.6 mg iberdomide QD were assigned and analyzed with the 0.3/0.6 iberdomide ALT QD group in the ATEP.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 100 Follow-Up 0.0
40.0
Week 96 0.0
40.0
Week 84 0.0
80.0
Week 72 0.0
80.0
Week 60 20.0
33.3
Week 48 20.0
50.0
Week 36 0.0
66.7
Week 24 20.0
83.3
Week 12 0.0
66.7
Week 4 14.3
0.0
Week 1 12.5
0.0
15. SecondaryOutcome
Title Terminal Phase Half-Life (T1/2) Of Iberdomide
Description Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Outcome Measure Data
Analysis Population Description
The Pharmacokinetic population included all participants in the safety population with at least one non-missing plasma concentration datum available.
 
Arm/Group title Part 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/0.3 mg ALT DaysPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QOD
Arm/Group Description Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 4531
Measure Type: Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
Day 29 11.32
9.39
11.85
8.46
Day 1 9.55
7.96
10.25
7.50
16. SecondaryOutcome
Title Time to Reach Maximum Concentration (Tmax) of Iberdomide
Description Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Outcome Measure Data
Analysis Population Description
The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
 
Arm/Group title Part 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/0.3 mg ALT DaysPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QOD
Arm/Group Description Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 4533
Measure Type: Median (Full Range)
Unit of Measure: days
Day 1 4.01
(2.0 to 27.3)
1.92
(0.95 to 4.0)
6.00
(3.0 to 25.8)
4.00
(2.05 to 4.08)
Day 29 2.02
(1.1 to 3.1)
3.00
(1.0 to 4.0)
2.00
(2.0 to 3.05)
4.00
(2.0 to 4.0)
17. SecondaryOutcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide
Description The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Outcome Measure Data
Analysis Population Description
The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
 
Arm/Group title Part 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/0.3 mg ALT DaysPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QOD
Arm/Group Description Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg and 0.3 mg on alternating days (ALT QD) for up to 84 days during the Part 1 treatment phase.Participants received 0.3 mg iberdomide capsules once a day (QD) for up to 84 days during the Part 1 treatment phase.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.
Overall Number of Participants Analyzed 4533
Measure Type: Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
Day 29 52.65
24.85
15.55
13.34
Day 1 38.73
34.15
11.29
10.82
Adverse Events
Time Frame TEAEs were monitored from the date of the first dose of IP until 28 days after the last dose of IP or study IP discontinuation in Part 1; median treatment duration was 12.0 weeks for the placebo, 0.3 mg Iberdomide QOD and 0.3 mg QD cohorts and 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts
Adverse Event Reporting Description For the ATEP, TEAEs were monitored from the date of the first dose of IP until 28 days after the last dose or study IP discontinuation; median duration of treatment was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
 
Arm/Group Title ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QDATEP: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.6 mg QDPart 1: Iberdomide 0.6 mg/ 0.3 mg ALT QDPart 1: Iberdomide 0.3 mg QDPart 1: Iberdomide 0.3 mg QODPart 1: Placebo
Arm/Group Description Participants originally randomized to iberdomide 0.6 mg capsules QD or 0.6 mg Iberdomide capsules alternating days with 0.3 mg iberdomide capsules or placebo capsules QD chorts (in these respective groups), during the Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days when entered into the active treatment extension phase up to 2 years.Participants originally assigned to the iberdomide 0.3 mg capsules QD or 0.3 mg Iberdomide capsules QOD or placebo cohorts (in these respective groups) in Part 1 treatment phase, were assigned 0.3 mg iberdomide capsules QD when entered into the active treatment extension phase (ATEP) and continued iberdomide 0.3 mg QD up to 2 years.Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase.Participants received iberdomide 0.6 mg and 0.3 mg on alternating days for up to 84 days during the Part 1 treatment phase.Participants received 0.3 mg iberdomide capsules once a day for up to 84 days during the Part 1 treatment phase.Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase.Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase.
All-Cause Mortality
  Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/8 (0.00%) 0/8 (0.00%) 0/8 (0.00%) 0/9 (0.00%) 0/9 (0.00%) 0/9 (0.00%) 0/8 (0.00%)
Total
Total, all-cause mortality 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Serious Adverse Events
  Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 2/8 (25.00%) 0/8 (0.00%) 0/8 (0.00%) 1/9 (11.11%) 1/9 (11.11%) 0/9 (0.00%) 4/8 (50.00%)
Eye disorders
Vitreous detachment 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Infections and infestations
Pneumonia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Nervous system disorders
Seizure 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Psychiatric disorders
Schizoaffective disorder 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Total
Total, serious adverse events 2 /8 (25.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 1 /9 (11.11%) 0 /9 (0.00%) 4 /8 (50.00%)
Vascular disorders
Deep vein thrombosis 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Show Other (Not Including Serious) Adverse Events
  Part 1: Placebo Part 1: Iberdomide 0.3 mg QOD Part 1: Iberdomide 0.3 mg QD Part 1: Iberdomide 0.6 mg/ 0.3 mg ALT QD Part 1: Iberdomide 0.6 mg QD ATEP: Iberdomide 0.3 mg QD ATEP: Iberdomide 0.6 mg/ 0.3 mg ALT QD
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 5/8 (62.50%) 7/8 (87.50%) 7/8 (87.50%) 8/9 (88.89%) 8/9 (88.89%) 9/9 (100.00%) 7/8 (87.50%)
Blood and lymphatic system disorders
Neutropenia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 2 /9 (22.22%) 1 /9 (11.11%) 1 /8 (12.50%)
Eosinophilia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Cardiac disorders
Palpitations 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Ear and labyrinth disorders
Vertigo 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Eye disorders
Dry eye 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Scleritis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Retinopathy hypertensive 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Ocular discomfort 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Lacrimation increased 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Keratitis 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Eye pain 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Episcleritis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Gastrointestinal disorders
Vomiting 1 /8 (12.50%) 0 /8 (0.00%) 1 /8 (12.50%) 1 /9 (11.11%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Toothache 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Pancreatitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Nausea 1 /8 (12.50%) 1 /8 (12.50%) 3 /8 (37.50%) 3 /9 (33.33%) 0 /9 (0.00%) 2 /9 (22.22%) 0 /8 (0.00%)
Lip blister 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Hiatus hernia 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Gingival bleeding 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Gastrooesophageal reflux disease 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Gastritis 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Food poisoning 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Flatulence 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Dyspepsia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Duodenal polyp 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Diarrhoea 1 /8 (12.50%) 1 /8 (12.50%) 1 /8 (12.50%) 2 /9 (22.22%) 2 /9 (22.22%) 1 /9 (11.11%) 3 /8 (37.50%)
Dental necrosis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Dental caries 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Constipation 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Cheilitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Abdominal pain upper 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Abdominal pain 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
General disorders
Swelling 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Oedema peripheral 1 /8 (12.50%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Influenza like illness 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Gait disturbance 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 2 /9 (22.22%) 0 /8 (0.00%)
Infections and infestations
Viral upper respiratory tract infection 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Urinary tract infection 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 2 /9 (22.22%) 2 /8 (25.00%)
Upper respiratory tract infection 1 /8 (12.50%) 1 /8 (12.50%) 1 /8 (12.50%) 1 /9 (11.11%) 1 /9 (11.11%) 4 /9 (44.44%) 3 /8 (37.50%)
Tooth abscess 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Staphylococcal infection 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Sinusitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 2 /9 (22.22%) 1 /8 (12.50%)
Pneumonia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 1 /9 (11.11%) 1 /8 (12.50%)
Pharyngitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Oral candidiasis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Onychomycosis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Nasopharyngitis 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 2 /9 (22.22%) 0 /8 (0.00%)
Lyme disease 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Laryngitis 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Influenza 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 1 /8 (12.50%)
Hordeolum 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Herpes virus infection 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Gastroenteritis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 1 /8 (12.50%)
Folliculitis 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Ear infection 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Conjunctivitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Bronchitis 0 /8 (0.00%) 0 /8 (0.00%) 2 /8 (25.00%) 0 /9 (0.00%) 0 /9 (0.00%) 3 /9 (33.33%) 3 /8 (37.50%)
Bacteriuria 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Acute sinusitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Injury, poisoning and procedural complications
Laceration 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Contusion 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 2 /9 (22.22%) 0 /8 (0.00%)
Investigations
Weight increased 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Neutrophil count decreased 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 1 /8 (12.50%)
Hepatic enzyme increased 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Metabolism and nutrition disorders
Vitamin D deficiency 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 2 /9 (22.22%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Hypovitaminosis 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Synovial cyst 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Pain in extremity 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 2 /9 (22.22%) 0 /8 (0.00%)
Osteoarthritis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 2 /9 (22.22%) 0 /8 (0.00%)
Neck pain 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Musculoskeletal pain 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 2 /8 (25.00%)
Muscular weakness 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Muscle twitching 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Muscle spasms 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Fibromyalgia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Bursitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Back pain 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Arthralgia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 1 /8 (12.50%)
Nervous system disorders
Small fibre neuropathy 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Nerve root compression 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Lethargy 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Headache 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Dizziness 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 2 /8 (25.00%)
Psychiatric disorders
Middle insomnia 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Irritability 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Insomnia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Generalised anxiety disorder 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Anxiety 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Renal and urinary disorders
Urinary incontinence 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Stress urinary incontinence 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Pollakiuria 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Reproductive system and breast disorders
Nipple disorder 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Menstruation irregular 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Menorrhagia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Galactorrhoea 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Dysmenorrhoea 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Cervical polyp 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 1 /8 (12.50%)
Pulmonary embolism 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Pleuritic pain 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Dyspnoea 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Cough 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 1 /9 (11.11%) 0 /9 (0.00%) 2 /8 (25.00%)
Asthma 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Skin and subcutaneous tissue disorders
Urticaria 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Skin lesion 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Rash papular 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Rash maculo-papular 0 /8 (0.00%) 1 /8 (12.50%) 0 /8 (0.00%) 1 /9 (11.11%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Rash macular 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Rash follicular 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Pruritus 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Prurigo 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Pain of skin 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Nail discolouration 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Hidradenitis 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /8 (12.50%)
Ecchymosis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Dermatitis 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 2 /9 (22.22%) 0 /9 (0.00%) 0 /8 (0.00%)
Blister 0 /8 (0.00%) 0 /8 (0.00%) 1 /8 (12.50%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Angioedema 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /9 (0.00%) 0 /8 (0.00%)
Alopecia 0 /8 (0.00%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 1 /9 (11.11%) 0 /8 (0.00%)
Total
Total, other adverse events 5 /8 (62.50%) 7 /8 (87.50%) 7 /8 (87.50%) 8 /9 (88.89%) 8 /9 (88.89%) 9 /9 (100.00%) 7 /8 (87.50%)
Vascular disorders
Deep vein thrombosis 1 /8 (12.50%) 0 /8 (0.00%) 0 /8 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /9 (0.00%) 0 /8 (0.00%)
Limitations and Caveats

More Information
Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.

Results Point of Contact
  • ClinicalTrials.gov Identifier: NCT02185040 History of Changes
  • Other Study ID Numbers: CC-220-SLE-001
  • First Submitted: July 7, 2014
  • First Posted: July 9, 2014
  • Results First Submitted: September 24, 2019
  • Results First Posted: March 19, 2020
  • Last Update Posted: March 19, 2020