A study to evaluate the efficacy and safety of bimekizumab in subjects with active nonradiographic axial spondyloarthritis

Phase 1

• Conditions: Nonradiographic axial spondyloarthritis; MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-003064-13-GB
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

-Male or female patients at least 18 years of age
-Patient has nonradiographic axial spondyloarthritis with all of the following criteria:
a) Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) 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.
-Patients must have inadequate response to NSAIDs, intolerance to administration of at least 1 NSAID, or contraindication(s) 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 AxSpA, eg, rheumatoid 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