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NOT YET RECRUITING
NCT07836283
PHASE3

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

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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

Official title: 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 - Randomized, Open-label, in Parallel Arms, Head to Head Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-15

Completion Date

2030-10-15

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DRUG

bimekizumab

BIMZELX® 160 mg, solution for injection in pre-filled syringe or pre-filled pen, administered subcutaneously at the dose of 160 mg every 4 weeks for 12 months

DRUG

adalimumab

Adalimumab will be administered at a single dose of 40 mg every 14 days using a pre-filled syringe or a pre-filled pen via subcutaneous injection

Locations (1)

CHU de ROUEN

Rouen, France