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

Completed · Phase 3 · Has a placebo group

Conditions studied: Nonradiographic Axial Spondyloarthritis

In brief

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).

Key facts

Study ID

NCT03928704

Run by

UCB Biopharma SRL

People needed

274

Starts

2019-04-25

Expected to finish

2023-04-17

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients at least 18 years of age
• Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:
• Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria
• Inflammatory back pain for at least 3 months
• Age at symptom onset of less than 45 years
• 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

You may not qualify if…

• 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

Where it is running

• As0010 50052 — Phoenix, Arizona, United States
• As0010 50062 — Sun City, Arizona, United States
• As0010 50060 — Upland, California, United States
• As0010 50059 — Ormond Beach, Florida, United States
• As0010 50056 — Sarasota, Florida, United States
• As0010 50015 — Hagerstown, Maryland, United States
• As0010 50016 — St Louis, Missouri, United States
• As0010 50055 — Portland, Oregon, United States
• As0010 50020 — Duncansville, Pennsylvania, United States
• As0010 50012 — Memphis, Tennessee, United States
• As0010 50057 — Dallas, Texas, United States
• As0010 50036 — Mesquite, Texas, United States
• As0010 50061 — Spokane, Washington, United States
• As0010 40004 — Brussels, Belgium
• As0010 40003 — Genk, Belgium
• As0010 40001 — Ghent, Belgium
• As0010 40002 — Merksem, Belgium
• As0010 40006 — Plovdiv, Bulgaria
• As0010 40007 — Plovdiv, Bulgaria
• As0010 40005 — Sofia, Bulgaria
• As0010 40008 — Sofia, Bulgaria
• As0010 20040 — Beijing, China
• As0010 20021 — Chengdu, China
• As0010 20019 — Guangzhou, China
• As0010 50131 — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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