A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE MOBILE 1)

UCB

Status and phase: Completed; Phase 3

Conditions: Nonradiographic Axial Spondyloarthritis

Treatments: Drug: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03928704

2017-003064-13 (EudraCT Number)

AS0010

Details and patient eligibility

About

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).

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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274 participants in 2 patient groups, including a placebo group

Bimekizumab

Experimental group

Description:

Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.

Treatment:

Drug: Bimekizumab

Placebo

Placebo Comparator group

Description:

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.

Treatment:

Other: Placebo

Drug: Bimekizumab