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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

ConditionAxial or Predominantly Axial SpondyloArthritis With or Without Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Rouen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male adult-patients aged between 18 and ≤ 60 years

Patient having an established diagnosis by a rheumatologist of axial or predominantly axial SpA with or without psoriasis fulfilling the 2009 ASAS classification criteria

SpA evolving > 3 months

bDMARD and JAKi naïve

Disqualifiers

Pregnant woman;

Woman of childbearing potential not using effective contraception;

Patient with an history of chest trauma and/or chest surgery;

Patient with an history of radiotherapy in the anterior thoracic region;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Patients receiving bimekizumab (BIMZELX) administered as monotherapy according to the recommendationExperimental treatment 1 intervention
Group B: Patients receiving adalimumab (HUMIRA or one of its biosimilars) alone according to recommendationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ASAS40 response

Spondyloarthritis international Society 40% response

Time frame
6 months

Secondary outcomes

1

average spontaneous ACW pain (measured on a NS)

Time frame
6 months
2

ASAS40 response

Time frame
12 months
3

spontaneous pain of the ACW

improvement of at least 50% of the spontaneous pain of the ACW

Time frame
12 months
4

Ankylosing Spondylitis Disease Activity Score (ASDAS)

proportion of patients in each group achieving (i) ASDAS-CRP \< 2.1 (low disease activity) or \< 1.3 (remission)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: