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A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

  • Clinicaltrials.gov identifier

    NCT03928704

  • Recruitment Status

    Recruiting

  • First Posted

    April 26, 2019

  • Last update posted

    June 4, 2021

Study Description

Brief summary:

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA).

  • Condition or Disease:Nonradiographic Axial Spondyloarthritis
  • Intervention/Treatment: Drug: Bimekizumab
    Other: Placebo
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 240 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: September 2021
  • Estimated Study Completion Date: September 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Bimekizumab
Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.

Other: Placebo
Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.

Outcome Measures

  • Primary Outcome Measures: 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16 [ Time Frame: Week 16 ]
    ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
  • Secondary Outcome Measures: 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16 [ Time Frame: Week 16 ]
    ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
  • 2. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
  • 3. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16 [ Time Frame: Week 16 ]
    ASAS20 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
  • 4. Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16 [ Time Frame: Week 16 ]
    The Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
  • 5. Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16 [ Time Frame: Week 16 ]
    Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) is achieved when there is a reduction (improvement) >= 2.0 in the Ankylosing Spondylitis Disease Activity Score (ASDAS) relative to Baseline. ASDAS is calculated as the sum of the following components: 0.121 × Total back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1) Total back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). High ASDAS scores mean worse disease. If a subjects achieves the ASDAS-MI it indicates a major improvement of their disease.
  • 6. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16 [ Time Frame: Week 16 ]
    The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
  • 7. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
  • 8. Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16 [ Time Frame: Baseline, Week 16 ]
    Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
  • 9. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
  • 10. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) score at Week 16 [ Time Frame: Baseline, Week 16 ]
    There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
  • 11. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
  • 12. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
  • 13. Enthesitis-free state based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
  • 14. Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 72) ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
  • 15. Incidence of treatment-emergent serious adverse events (SAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 72) ]
    A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
  • 16. Treatment-emergent adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study [ Time Frame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 72) ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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:

- Male or female patients at least 18 years of age

- Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the
following criteria:

1. Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis
International Society (ASAS) classification criteria

2. Inflammatory back pain for at least 3 months

3. Age at symptom onset of less than 45 years

4. NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)

- Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
>=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale

- Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or
elevated C-reactive protein

- Subjects had to have either failed to respond to 2 different nonsteroidal
anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4
weeks or have a history of intolerance to or a contraindication to NSAID therapy

- Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have
experienced an inadequate response or intolerance to treatment given at an approved
dose for at least 12 weeks

- Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics,
corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ),
hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific
requirements prior to study entry

Exclusion Criteria:

- Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα
biological response modifiers, or any interleukin (IL)-17 biological response modifier

- Active infection or history of recent serious infections

- Viral hepatitis B or C or human immunodeficiency virus (HIV) infection

- Any live (includes attenuated) vaccination within the 8 weeks prior to entering the
study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the
study

- Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current
or history of nontuberculous mycobacterium (NTMB) infection

- Subject has any active malignancy or history of malignancy within 5 years prior to the
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
carcinoma or in situ cervical cancer

- Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA),
including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis,
systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of
Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are
allowed as long as they have no active symptomatic disease when entering the study

- Presence of active suicidal ideation, or moderately severe major depression or severe
major depression

- Female patients who are breastfeeding, pregnant, or planning to become pregnant during
the study

- Subject has a history of chronic alcohol or drug abuse within 6 months prior to
Screening

Contacts and Locations

Contacts

Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations

United States, Arizona
As0010 50052
Phoenix

United States, Arizona
As0010 50058
Phoenix

United States, Arizona
As0010 50131
Phoenix

United States, Arizona
As0010 50062
Sun City

United States, California
As0010 50060
Upland

United States, Florida
As0010 50059
Ormond Beach

United States, Florida
As0010 50056
Sarasota

United States, Maryland
As0010 50015
Hagerstown

United States, Missouri
As0010 50016
Saint Louis

United States, Ohio
As0010 50116
Cleveland

United States, Oklahoma
As0010 50054
Oklahoma City

United States, Oregon
As0010 50055
Portland

United States, Pennsylvania
As0010 50020
Duncansville

United States, Tennessee
As0010 50001
Jacksonville

United States, Tennessee
As0010 50012
Memphis

United States, Texas
As0010 50053
Austin

United States, Texas
As0010 50057
Dallas

United States, Texas
As0010 50036
Mesquite

United States, Washington
As0010 50027
Seattle

United States, Washington
As0010 50061
Spokane

Belgium
As001 40004
Brussels

Belgium
As001 40003
Genk

Belgium
As0010 40001
Gent

Belgium
As001 40002
Merksem

Bulgaria
As0010 40006
Plovdiv

Bulgaria
As0010 40007
Plovdiv

Bulgaria
As0010 40005
Sofia

Bulgaria
As0010 40008
Sofia

China
As0010 20040
Beijing

China
As0010 20021
Chengdu

China
As0010 20019
Guangzhou

China
As0010 20024
Nanjing

China
As0010 20018
Shanghai

China
As0010 20020
Shanghai

China
As0010 20026
Shanghai

China
As0010 20025
Wenzhou

Czechia
As0010 40011
Brno

Czechia
As0010 40009
Pardubice

Czechia
As0010 40013
Praha 11

Czechia
As0010 40016
Praha 2

Czechia
As0010 40015
Praha 3

Czechia
As0010 40014
Praha 4

Czechia
As0010 40010
Uherské Hradiště

Czechia
As0010 40012
Zlín

France
As0010 40018
Boulogne-Billancourt

France
As0010 40022
Limoges

France
As0010 40021
Orléans

Germany
As0010 40025
Berlin

Germany
As0010 40028
Berlin

Germany
As0010 40029
Hamburg

Germany
As0010 40024
Hannover

Germany
As0010 40027
Herne

Germany
As0010 40078
Leipzig

Germany
As0010 40026
Ratingen

Hungary
As0010 40032
Debrecen

Hungary
As0010 40031
Szeged

Hungary
As0010 40033
Szekesfehervar

Hungary
As0010 40080
Szombathely

Japan
As0010 20030
Chuo Ku

Japan
As0010 20047
Himeji-shi

Japan
As0010 20039
Iruma-Gun

Japan
As0010 20036
Kawachi-Nagano

Japan
As0010 20045
Kita-Gun

Japan
As0010 20065
Kitakyushu

Japan
As0010 20038
Nankoku

Japan
As0010 20037
Osaka

Japan
As0010 20084
Saga

Japan
As0010 20048
Saitama

Japan
As0010 20031
Sapporo

Japan
As0010 20042
Sasebo

Japan
As0010 20032
Suita

Japan
As0010 20035
Tokyo

Netherlands
As0010 40034
Amsterdam

Netherlands
As0010 40035
Rotterdam

Poland
As0010 40038
Elbląg

Poland
As0010 40042
Krakow

Poland
As0010 40037
Lublin

Poland
As0010 40044
Poznań

Poland
As0010 40040
Torun

Poland
As0010 40041
Warsaw

Poland
As0010 40039
Wrocław

Poland
As0010 40043
Wrocław

Spain
As0010 40045
Coruna

Spain
As0010 40046
Córdoba

Spain
As0010 40047
Madrid

Spain
As0010 40048
Santiago De Compostela

Spain
As0010 40049
Sevilla

Turkey
As0010 40052
Ankara

Turkey
As0010 40053
Ankara

Turkey
As0010 40050
Istanbul

Turkey
As0010 40051
Izmir

United Kingdom
As0010 40057
Edinburgh

United Kingdom
As0010 40056
Leeds

United Kingdom
As0010 40054
London

United Kingdom
As0010 40055
Norwich

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

Study Director: UCB Cares 001 844 599 2273 (UCB)

More Information

  • Responsible Party: UCB Biopharma SRL
  • ClinicalTrials.gov Identifier: NCT03928704 History of Changes
  • Other Study ID Numbers: AS0010, 2017-003064-13
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: June 4, 2021
  • Last Verified: June 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)
  • Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
  • Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
  • URL: http://www.Vivli.org
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by UCB Biopharma SRL: Nonradiographic axial spondyloarthritis
    Axial spondyloarthritis
    Nr-axSpA
    Bimekizumab
  • Additional relevant MeSH terms: Spondylarthritis