Comparison of Bimekizumab versus Adalimumab for the Treatment of Anterior Chest Wall Pain in Patients with Active Axial Spondyloarthritis Refractory to NSAIDs
- Trial ID
- 2025-520632-42-00
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to demonstrate the superiority of bimekizumab, a dual inhibitor of IL-17A and IL-17F, compared to adalimumab in achieving an ASAS40 response at 6 months in patients with active axial spondyloarthritis who are refractory to NSAIDs and have anterior chest wall pain. 5
Secondary objectives include:
- Demonstrating superiority in controlling anterior chest wall pain during the first 6 months.
- Comparing ASAS40 responses at 1, 3, and 12 months.
- Evaluating mean MASES scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) states, specifically the proportion of patients achieving low disease activity or remission.
- Assessing changes in spontaneous pain and the number of painful joints at the anterior chest wall.
- Developing a composite score for specific assessment of anterior chest wall involvement using clinical and imaging data, such as MRI or ultrasound.
- Comparing efficacy regarding global disease activity, therapeutic maintenance rates at 1 year, and the Bath Ankylosing Spondylitis Functional Index (BASFI).
- Evaluating impact on chest expansion and quality of life via the EuroQol-5D-5L.
- Measuring changes in NSAID consumption using the ASAS-NSAID score.
- Assessing safety and the incidence of psoriatic arthritis flares.
- Comparing effects on inflammatory lesions via MRI and Power Doppler ultrasound.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, aged 18 to 60 years, diagnosed with axial spondyloarthritis with or without psoriasis. Eligible individuals must be bDMARD and/or JAKi naïve and have demonstrated an inadequate response to at least two non-steroidal anti-inflammatory drugs or an intolerance to such medications. Participants must present with active disease, defined by an ASDAS-CRP score of ≥ 2.1, and spontaneous pain in the enthesis of the costovertebral joint. Inclusion requires the presence of at least one inflammatory lesion in the costovertebral joint as confirmed by magnetic resonance imaging, ultrasonography, scintigraphy, or computed tomography. The study includes both male and female subjects, with specific requirements for women of childbearing potential regarding contraception and pregnancy testing.
Plans and Procedures
This phase III, randomized, open-label, parallel-arm, head-to-head trial evaluates the efficacy and safety of bimekizumab compared to adalimumab in patients with active axial spondyloarthritis. The study focuses on individuals experiencing anterior chest wall pain that is refractory to non-steroidal anti-inflammatory drugs. Following a screening visit to confirm eligibility based on ASAS classification criteria and imaging evidence of inflammatory lesions, participants are assigned to receive either bimekizumab or adalimumab via injection. The primary efficacy measure is the ASAS40 response at the 6-month assessment. Throughout the study, spontaneous pain is monitored using weekly self-evaluations. The total trial duration for recruitment and completion is estimated to span from March 2026 to March 2029.
Treatment
The experimental treatment consists of bimekizumab, administered as Bimzelx. The pharmaceutical form is a solution for injection provided in a pre-filled syringe. Each dose contains 160 mg of the active substance, which is administered via injection.
The comparator treatment is adalimumab. This substance is administered as a 40 mg injection.
Efficacy
The primary efficacy assessment is the ASAS40 response at the 6-month visit. This endpoint represents a 40% or greater improvement in three of the following four domains: BASFI, patient global assessment of disease activity, total spine pain and inflammation, and morning stiffness.
Secondary efficacy evaluation consists of the average spontaneous anterior chest wall pain, measured on a numerical scale, from baseline to the 6-month visit. This parameter is assessed through weekly repetitive self-evaluations of pain collected at different times of the day using a dedicated digital tool.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Female or male adult-patients aged between 18 and ≤ 60 years
- 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.
- 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
- 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 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)
Exclusion Criteria
- Pregnant woman;
- Woman of childbearing potential not using 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);
- 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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Yet Recruiting | 02 Mar 2026 | 150 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Bimzelx 160 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | INJECTION | 160 | 12 | PRD9159766 |
ADALIMUMAB | Comparator | — | INJECTION | 40 | 12 | SUB20016 |