drugset / Trial / NCT07836283

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

NCT07836283 ↗

Phase 3 Not yet recruiting 150 enrolled University Hospital, Rouen
RandomizedParallel-groupSingle-blindTreatment

Summary

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

Timeline

Start
2026-10-15
Primary completion
2030-04-15
Completion
2030-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Bimekizumab Monoclonal antibody 160 mg Subcutaneous

Indications