A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
- Conditions
- Non-Radiographic Axial Spondyloarthritis - Bechterew's disease10003816
- Registration Number
- NL-OMON55386
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
-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 had to have either failed to respond to 2 different NSAIDs given at
the maxiumum tolereated dose for a total of 4 weeks or have a history of
intolerence to or a contraindication to NSAID therapy. -Patients who have taken
a tumor necrosis factor alpha (TNF*) 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
-Treatment with more than 1 TNF* inhibitor and/or more than 2 additional
non-TNF* 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Study variables:<br /><br>Efficacy:<br /><br><br /><br>Primary efficacy variable:<br /><br>* ASAS40 response at Week 16<br /><br><br /><br><br /><br>Safety:<br /><br><br /><br>Primary safety variable:<br /><br>Not applicable</p><br>
- Secondary Outcome Measures
Name Time Method