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 (ThoracSPA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-04-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 18

1. The major secondary objective is to demonstrate the superiority of BKZ (dual inhibition of IL-17A and IL-17F) in controlling ACW pain in the 6 first months compared to ADA.
2. 1. To compare BKZ and ADA on ASAS40 responses at 1, 3 and 12 months
3. 2. To compare BKZ and ADA on average MASES scores
4. 3. To compare BKZ and ADA on average Ankylosing Spondylitis Disease Activity Score (ASDAS) states with the proportion of patients in each group achieving (i) ASDAS-CRP < 2.1 (low disease activity) or < 1.3 (remission)
5. 4. To compare BKZ and ADA on the change of improvement of at least 50% of the spontaneous pain of the ACW;
6. 5. To compare BKZ and ADA on the change of improvement of at least 50% in the number of painful joints of the ACW at the pressure of the 17 joints.
7. 6. To develop a composite score for more specific assessment of ACW involvement from a panel of data, either exclusively clinical (number of painful joints on 17 assessed; part of MASES score; pain NS of the ACW; chest expansion,..), or combining clinical and imaging (ACW MRI or US score…)
8. 7. To compare the efficacy of BKZ and ADA on global disease activity using innovative composite scores (validated for the study)
9. 8. To compare the efficacy of BKZ and ADA on the therapeutic maintenance rate at 1 year
10. 9. To assess the safety of BKZ and ADA
11. 10. To compare the effect of BKZ and ADA on the inflammatory lesions of the ACW highlighted by MRI by studying the evolution over a period of 6 months of an MRI score reflecting the activity of the disease at this painful site
12. 11. To compare the impact of both drugs on inflammatory lesions of the ACW highlighted by Power Doppler (PD)-US
13. 12. To compare the impact of ADA versus BKZ on the incidence of AAU flares
14. 13. To compare the impact of ADA versus BKZ on States of Bath Ankylosing Spondylitis Functional index (BASFI)
15. 14. To compare the impact of ADA versus BKZ on the chest expansion
16. 15. To compare the impact of ADA versus BKZ on the change from baseline in EuroQol-5D-5L
17. 16. To compare the impact of ADA versus BKZ on the proportion of patients with drug maintenance at 1 year in each group;
18. 17. To compare the impact of ADA versus BKZ on the consumption of NSAIDs during the follow-up period using the ASAS-NSAID-score for those having a score > 0 at baseline with proportion of patients achieving a 50% reduction of ASAS-NSAID score at months 6 and 12 and an ASAS-NSAID score < 10 at these 2 time points

Conditions and MedDRA coding

axial or predominantly axial SpA with or without psoriasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. • Female or male adult-patients aged between 18 and ≤ 60 years
2. • Patient having read and understood the information letter and signed the consent form
3. • Patient affiliated with, or beneficiary of a social security (health insurance) category
4. • 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
5. • Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
6. • 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.
7. • Patient having an established diagnosis by a rheumatologist of axial or predominantly axial SpA with or without psoriasis fulfilling the 2009 ASAS classification criteria
8. • SpA evolving > 3 months
9. • bDMARD and JAKi naïve
10. • 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
11. • Patient with active disease defined by ASDAS-CRP ≥ 2,1
12. • Patient with spontaneous pain of the ACW ≥ 4/10 on NS
13. • Patient with tenderness at the pressure of at least one of the four chondro-sternal joints of enthesitis MASES score
14. • Stable dose of ongoing drug prescriptions (analgesics, NSAIDs) during the last month
15. • 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 15

1. Pregnant woman;
2. Woman of childbearing potential not using contraception;
3. Patient with an history of chest trauma and/or chest surgery;
4. Patient with an history of radiotherapy in the anterior thoracic region;
5. Infiltration of a cortisone derivative performed in one or more joints of the ACW during the last 3 months
6. Satisfaction of the 2016 ACR diagnostic criteria of fibromyalgia (Appendix 9);
7. Concomitant inflammatory bowel disease (IBD) (contraindication for IL-17i use);
8. Moderate or severe plaque psoriasis requiring higher doses of ADA or BKZ;
9. Analgesic treatment with strong opioids (WHO level III) with an average daily dose > 30 mg/day of morphine (or equivalent)
10. One of the pre-biotherapy assessment not respected (viral serology, oral health consultation, evaluation of active or inactive (“latent”) tuberculosis infection, …).
11. 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)
12. 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).
13. Patient with a contraindication to performing MRI in centers performing MRI for the study
14. Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
15. Patient participating or having participated in a therapeutic drug trial in the 3 months prior to inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the ASAS40 response (Spondyloarthritis international Society 40% response) at the 6-month visit. ASAS40 indicates a ≥ 40% improvement in 3 of the 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (Morning stiffness)

Secondary endpoints 1

1. The endpoint will be the average spontaneous ACW pain (measured on a NS) between baseline and the 6-month visit using repetitive self-evaluations of pain collected every week at different day times (dedicaded digital tool).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

PICOCHE

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

PICOCHE

Locations

1 EU/EEA country · 28 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications