Status: Not yet recruiting
Evaluation of the Efficacy and Safety of Bimekizumab (BZK) or Adalimumab (ADA) in the Treatment of Anterior Chest Wall Pain Associated With Active Axial Spondyloarthritis Refractory to NSAIDs With Hypothesis of Superiority of Bimekizumab
The primary objective is to demonstrate the superiority of BKZ (dual inhibition of IL-17A and IL-17F) on the ASAS40 response at 6 months compared to a reference treatment (ADA) in patients with active axial or predominantly axial SpA, bDMARD and/or JAKi naïve, with an inadequate response to NSAIDs, one of the main complaints of which being focused on ACW. Since the study is a pragmatic trial aiming at changing prescriptions, the treatment policy estimand strategy will be used
Participants needed: 150
Trial details
Phase: Phase 3Age: 18-60Biological sex: AllType: InterventionalSponsor: University Hospital, RouenUpdated: Sep 23, 2026Locations: 1
Eligibility criteria
Female or male adult-patients aged between 18 and ≤ 60 years [+14]
Pregnant woman; [+19]