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A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

  • Clinicaltrials.gov identifier

    NCT04800315

  • Recruitment Status

    Recruiting

  • First Posted

    March 16, 2021

  • Last update posted

    December 3, 2021

Study Description

Brief summary:

The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).

  • Condition or Disease:Dermatitis, Atopic
    Eczema
  • Intervention/Treatment: Drug: CC-93538
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 2, Multicenter, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Cendakimab (CC-93538) in Adult Subjects With Moderate to Severe Atopic Dermatitis
  • Actual Study Start Date: May 2021
  • Estimated Primary Completion Date: August 2022
  • Estimated Study Completion Date: August 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Dose 1: CC-93538 SC QW
Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
Drug: CC-93538
Subcutaneous once weekly
Experimental: Dose 2: CC-93538 and Placebo SC Q2W
Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.
Drug: CC-93538
Subcutaneous once weekly

Other: Placebo
Subcutaneous Every other week
Experimental: Dose 3: CC-93538 and Placebo SC Q2W
Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind.
Drug: CC-93538
Subcutaneous once weekly

Other: Placebo
Subcutaneous Every other week
Placebo Comparator: Placebo SC QW
Administration of placebo each week.
Other: Placebo
Subcutaneous Every other week

Outcome Measures

  • Primary Outcome Measures: 1. Percent change in EASI from Baseline at Week 16 [ Time Frame: Up to week 16 ]
    The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)
  • Secondary Outcome Measures: 1. Proportion of participants with an vIGAAD score from Baseline at Week 16 [ Time Frame: Up to week 16 ]
    The Validated Investigator Global Assessment (vIGA)-AD is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded).
  • 2. Proportion of participants with at least a 75% improvement from Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 [ Time Frame: Up to week 16 ]
    The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD.
  • 3. Percent change from Baseline in Pruritus Numerical Rating Scale (NRS) at Week 16 [ Time Frame: Up to week 16 ]
    Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
  • 4. Proportion of participants with Pruritus NRS change of ≥ 4 points from Baseline at Week 16 [ Time Frame: Up to week 16 ]
    Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
  • 5. Time to achieve at least 4 points of improvement in the severity of pruritus NRS scale in the first 16 weeks of treatment [ Time Frame: Up to week 16 ]
    Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
  • 6. Proportion of participants with at least a 90% improvement from Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 [ Time Frame: Up to week 16 ]
    The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)
  • 7. Mean change in SCORAD Scores from Baseline at Week 16 [ Time Frame: Up to week 16 ]
    The Scoring Atopic Dermatitis Index (SCORAD) is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10).
  • 8. Percent change in BSA involved with AD from baseline at Week 16 [ Time Frame: Up to week 16 ]
    Percentage body surface area of the skin that displays signs or symptoms consistent with atopic dermatitis
  • 9. Incidence of Adverse Events (AEs) [ Time Frame: Up to week 32 ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
  • 10. Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538 [ Time Frame: Up to week 32 ]
    Evaluated by the presence of anti-drug antibodies to CC-93538
  • 11. Pharmacokinetics-Cthrough [ Time Frame: Up to week 32 ]
    Serum trough concentration of CC-93538

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF). Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1). Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1): Body Surface Area (BSA) ≥ 10%, and EASI score ≥ 16, and vIGA-AD ≥ 3, and Pruritus Numeric Rating Scale (NRS) severity score ≥ 4. Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease. Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study. Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study. Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study. Female participants of childbearing potential must agree to practice a highly effective method of contraception. Exclusion Criteria: The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD. Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline). Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit. Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit. Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit. Treatment with immunomodulatory biologics Concurrent treatment with another IP Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study. Active parasitic/helminthic infection or a suspected parasitic/helminthic infection. Ongoing infection A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com

Locations

United States, Alabama
Clinical Research Center of Alabama
Birmingham

United States, Alabama
Cahaba Dermatology
Birmingham

United States, Arkansas
Burke Pharmaceutical Research
Hot Springs

United States, California
First OC Dermatology
Fountain Valley

United States, District of Columbia
George Washington University School of Medicine and Health Sciences
Washington

United States, Florida
Total Vein and Skin, LLC
Boynton Beach

United States, Florida
Palm Beach Dermatology Group
Delray Beach

United States, Florida
GCP Global Clinical Professionals
Saint Petersburg

United States, Florida
ForCare Clinical Research
Tampa

United States, Florida
Metabolic Research Institute Inc
West Palm Beach

United States, Georgia
Aeroallergy Research Labs of Savannah
Savannah

United States, Illinois
Sneeze Wheeze and Itch Associates LLC
Springfield

United States, Indiana
DS Research
Clarksville

United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis

United States, Indiana
Randall Dermatology
West Lafayette

United States, Indiana
Randall Dermatology - Westfield Campus
Westfield

United States, Kansas
Kansas City Dermatology P.A.
Overland Park

United States, Kentucky
DS Research
Louisville

United States, Maryland
DermAssociates
Silver Spring

United States, Michigan
Skin Research Clarkston/Clarkston Dermatology
Clarkston

United States, Nebraska
Skin Specialists PC
Omaha

United States, Nevada
JDR Dermatology Research, LLC
Las Vegas

United States, New Jersey
Skin Laser and Surgery Specialists of New York and New Jersey LLC
Hackensack

United States, New York
Icahn School of Medicine at Mount Sinai
Great Neck

United States, New York
Sadick Research Group
New York

United States, Oklahoma
Central Sooner Research
Norman

United States, Oklahoma
Vital Prospects Clinical Research Institute PC - CRN - PPDS
Tulsa

United States, Oregon
Oregon Medical Research Center, P.C.
Portland

United States, Rhode Island
Clinical Partners, LLC
Johnston

United States, Tennessee
International Clinical Research
Murfreesboro

United States, Virginia
Clinical Research Partners LLC
Henrico

United States, Virginia
West End Dermatology Associates
Richmond

Canada, Alberta
Institute for Skin Advancement
Calgary

Canada, Alberta
Rao Dermatology
Edmonton

Canada, British Columbia
Dr. Chih-ho Hong Medical Inc.
Surrey

Canada, British Columbia
Enverus Medical Research
Surrey

Canada, Manitoba
Wiseman Dermatology Research Inc.
Winnipeg

Canada, Ontario
Lynderm Research Inc
Markham

Canada, Ontario
DermEdge
Mississauga

Canada, Ontario
The Centre for Clinical Trials Inc.
Oakville

Canada
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
Quebec

China
Kawashima Dermatology
Ichikawa

China
Miyata Dermatology Clinic
Matsudo

Czechia
Kozni ambulance Kutna Hora
Kutná Hora

Czechia
Dermamedica
Náchod

Czechia
CCBR Ostrava
Ostrava

Czechia
Center for Clinical and Basic Research Czech Pardubice
Pardubice

Czechia
CCBR Czech Prague s.r.o.
Prague

Czechia
FN Motol
Praha 5

Czechia
Clintrial
Praha

Czechia
Dermatologicka Ambulance MUDr. Petr Trestik
Svitavy

Japan
Fukuoka University Hospital
Fukuoka-shi, Fukuoka

Japan
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka

Japan
Ichinomiya Municipal Hospital
Ichinomiya

Japan
Teikyo University Hospital
Itabashi-ku

Japan
Saruwatari Dermatology Clinic
Kagoshima

Japan
Yamanashi Prefectual Central Hospital
Kofu

Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto-City

Japan
Charme-Clinique
Matsudo

Japan
Nagoya City University Hospital
Nagoya

Japan
Takagi Dermatology
Obihiro

Japan
Nakatsu Hifuka Clinic
Osaka

Japan
Sapporo Skin Clinic
Sapporo-shi, Hokkaido

Japan
Medical Corporation Kojinkai Housui Sogo Medical Clinic
Sapporo

Japan
Tokyo Medical University Hospital
Shinjuku

Japan
Nomura Dermatology Clinic
Yokohoma City, Kanagawa

Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk

Poland
Care Clinic
Katowice

Poland
Centrum Medyczne Angelius Provita
Katowice

Poland
Centrum Medyczne Dermoklinika
Lodz

Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn

Poland
Klinika Zdybski
Ostrowiec Świętokrzyski

Poland
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
Szczecin

Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne
Szczecin

Poland
High-Med Przychodnia Specjalistyczna
Warsaw

Poland
Klinika Ambroziak Estederm
Warsaw

Poland
Wojskowy Instytut Medyczny
Warsaw

Poland
Centrum Zdrowia WroMedica
Wroclaw

Poland
Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
Wrocław

Poland
Specjalistyczne Gabinety Lekarskie DERMED
Łódź

Sponsors and Collaborators

Celgene

Investigators

Study Director: Steven Draikiwicz, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04800315 History of Changes
  • Other Study ID Numbers: CC-93538-AD-001, 1111-1260-5462, 2020-005212-22
  • First Posted: March 16, 2021 Key Record Dates
  • Last Update Posted: December 3, 2021
  • Last Verified: December 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Atopic Dermatitis
    Cendakimab
    CC-93538
  • Additional relevant MeSH terms: Dermatitis, Atopic
    Dermatitis
    Eczema
    Skin Diseases
    Skin Diseases, Genetic
    Genetic Diseases, Inborn
    Skin Diseases, Eczematous
    Hypersensitivity, Immediate
    Hypersensitivity
    Immune System Diseases