A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
- Conditions
- Active ankylosing spondylitis - Bechterew's disease10003816
- Registration Number
- NL-OMON55807
- 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, -Subject has ankylosing
spondylitis as per the Modified New York (mNY) criteria with documented
radiologic evidence, and at least 3 months of symptoms with age at symptom
onset less than 45 years, -Subjects has moderate-to-severe active disease
defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) *4 AND
spinal pain *4 on a 0 to 10 Numeric Rating Scale, -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
-Total ankylosis of the spine, -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 at any time are excluded,
-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 AS, 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><br /><br>Efficacy:<br /><br>Primary efficacy variable:<br /><br>SpondyloArthritis International Society 40% (ASAS40) response at Week 16.<br /><br><br /><br>Safety:<br /><br><br /><br>Primary safety variable:<br /><br>Not applicable</p><br>
- Secondary Outcome Measures
Name Time Method