Ankylosing Spondylitis MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has active AS, determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for >=3 months and age of onset =4 --Spinal pain >=4 on a 0 to 10 NRS (from BASDAI item 2) - Subjects must have at least 1 of the following: -- inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy -- intolerance to administration of at least 1 NSAID -- contraindication(s) to NSAID therapy - Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline - Subjects taking corticosteroids must be on an average daily dose of =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg,rheumatoid arhritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis - Subjects with any current sign or symptom that may indicate an active infection (except for the common cold) - Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit - Subjects receiving any live vaccination within the 8 weeks prior to Baseline - Subjects with known tubercolosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection - Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be indlucded: a) <= 3 excised or ablated basal cell carcinomas of the skin b) One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening c) Actinic keratosis (-es) d) Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the dose-response based on the efficacy of bimekizumab;Secondary Objective: - assess the efficacy of the individual dose regimens of bimekizumab compared to placebo - assess the safety and tolerability of bimekizumab - assess the pharmacokinetics (PK) of bimekizumab - assess the pharmacodynamics (PD) of bimekizumab - assess the immunogenicity of bimekizumab - assess the exposure: response relationship of bimekizumab as it relates to efficacy and safety;Primary end point(s): Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 - Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12 - Subjects with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12 - Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI);Timepoint(s) of evaluation of this end point: Baseline Week 12 | — |
Countries
Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Romania, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed