Axial or Predominantly Axial SpondyloArthritis With or Without PsoriasisPhase 3ThoracSPANCT07836283
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
A Phase 3 study testing bimekizumab and adalimumab in people with Axial or Predominantly Axial SpondyloArthritis With or Without Psoriasis, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Axial or Predominantly Axial SpondyloArthritis With or Without Psoriasis
- What is being tested?
- bimekizumab and adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 15 Oct 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- History of inadequate response to at least 2 NSAIDs at a therapeutic dose range for >= 2 weeks each or intolerance to >= 2 NSAIDs for at least 3 months
- Patient with active disease defined by ASDAS-CRP ≥ 2,1
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- Patient with spontaneous pain of the ACW ≥ 4 /10 on NS
- Patient with tenderness at the pressure of at least one of the four chondro-sternal joints of enthesitis MASES score
- Stable dose of ongoing drug prescriptions (analgesics, NSAIDs) during the last month
- Patient having read and understood the information letter and signed the consent form
- Patient affiliated with, or beneficiary of a social security (health insurance) category
- Women of childbearing potential (in accordance with CTCG recommendations, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile):
- with effective contraception (Cf. CTCG recommendations) (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) since 1 month, during treatment and for 5 months after cessation of ADA and BKZ treatments and,
- a negative blood pregnancy test by b-HCG at inclusion
- Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- Postmenopausal women: In accordance with CTCG recommendations, a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
Who cannot join
- 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;
- Infiltration of a cortisone derivative performed in one or more joints of the ACW during the last 3 months;
- Satisfaction of the 2016 ACR diagnostic criteria of fibromyalgia (Appendix 9);
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- Concomitant inflammatory bowel disease (IBD) (contraindication for IL-17i use);
- Moderate or severe plaque psoriasis requiring higher doses of ADA or BKZ;
- Analgesic treatment with strong opioids (WHO level III) with an average daily dose > 30 mg/day of morphine (or equivalent)
- One of the pre-biotherapy assessment not respected (viral serology, oral health consultation, evaluation of active or inactive ("latent") tuberculosis infection, …).
- Patient with contraindication to BIMZELX® 160 mg, solution for injection in pre-filled syringe or pre-filled pen:
- Hypersensitivity to the active substance or to any of the excipients,
- Clinically important active infections (e.g. active tuberculosis)
- Patient with contraindication to adalimumab (HUMIRA or one of its biosimilars (AMGEVITA, IMRALDI, HULIO, IDACIO, YUFLYMA, AMSPARITY, HYRIMOZ, HUKYNDRA)) :
- Hypersensitivity to the active substance or to any of the excipients,
- Active tuberculosis or other severe infections such as sepsis and opportunistic infections,
- Moderate to severe heart failure (NYHA classes III/IV).
- Patient with a contraindication to performing MRI in centers performing MRI for the study
- Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
- Patient participating or having participated in a therapeutic drug trial in the 3 months prior to inclusion
- Randomization criteria :
- Patient with at least one unequivocal inflammatory lesion of the ACW highlighted by MRI and/or ultrasonography and/or scintigraphy and/or CT scan < 6 months at the time of randomization, validated by the investigator of each center (no central reading for inclusion procedure)
- Woman of childbearing potential with negative urinary pregnancy test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Armelle Guidotti contact
France1 site
CHU de ROUEN
Rouen
Olivier VITTECOQ, +33 232888990, olivier.vittecoq@chu-rouen.fr
Olivier VITTECOQ
About this study
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
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
- Being tested
- bimekizumab, adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimekizumabDrug
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
adalimumabDrug
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 group | Role | What they receive |
|---|---|---|
| Patients receiving bimekizumab (BIMZELX) administered as monotherapy according to the recommendation | Experimental | Not described Receives: Drug: bimekizumab |
| Patients receiving adalimumab (HUMIRA or one of its biosimilars) alone according to recommendations | Active comparator | Not described Receives: Drug: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASAS40 response
Spondyloarthritis international Society 40% response
Measured: 6 months
Secondary outcomes (10)
average spontaneous ACW pain (measured on a NS)
Measured: 6 months
ASAS40 response
Measured: 12 months
spontaneous pain of the ACW
improvement of at least 50% of the spontaneous pain of the ACW
Measured: 12 months
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)
Measured: 12 months
number of painful joints of the ACW at the pressure of the 17 joints
Measured: 12 months
absence of withdrawal of the study treatment
Measured: 12 months
Adverse events
Measured: 12 months
States of Bath Ankylosing Spondylitis Functional index (BASFI)
Measured: 12 months
EuroQol-5D-5L
Measured: 12 months
ASAS-NSAID score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Apr 2030 (estimated)
- Study completion15 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial or Predominantly Axial SpondyloArthritis With or Without PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836283
- Sponsor's protocol ID
- 2023/0299/HP
- Other IDs
- 2025-520632-42-00, 2025
- Acronym
- ThoracSPA
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No