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
Study ID
NCT07836283
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Axial or Predominantly Axial SpondyloArthritis With or Without Psoriasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • bimekizumab — DRUG
    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
  • adalimumab — DRUG
    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

Study Details

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

Key Dates

First listed
Sep 23, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Apr 15, 2030
Completion
Oct 15, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients receiving bimekizumab (BIMZELX) administered as monotherapy according to the recommendation
  • Active Comparator: Patients receiving adalimumab (HUMIRA or one of its biosimilars) alone according to recommendations

Primary Outcome Measure

ASAS40 response [ Time Frame: 6 months ]

Central Contacts