A study to evaluate the efficacy and safety ofbimekizumab in subjects with activenonradiographic axial spondyloarthritis

Phase 1

Conditions: onradiographic axial spondyloarthritis
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2017-003064-13-BE

Lead Sponsor: CB Biopharma SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 240

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:
a) Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS)classification criteria
b) Inflammatory back pain for at least 3 months
c) Age at symptom onset of less than 45 years.
d) 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 (TNFa) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 237
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

-Treatment with more than 1 TNFa inhibitor and/or more than 2 additional non-TNFa 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate the efficacy of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA);Secondary Objective: - Assess the efficacy of bimekizumab compared to placebo<br>- Assess the safety and tolerability of bimekizumab<br>- Assess the impact of bimekizumab on patient-reported quality of life<br>- Assess the impact of bimekizumab on spinal mobility<br>- Assess the impact of bimekizumab on enthesitis and on peripheral arthritis<br>;Primary end point(s): Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16<br>;Timepoint(s) of evaluation of this end point: Week 16<br>

Secondary Outcome Measures

Name	Time	Method

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