Ustekinumab for mucocutaneous Behçet's syndrome

Observational Study Assessing the Biosimilar of Ustekinumab in Active Mucocutaneous Behçet's Syndrome Refractory or Intolerant to Conventional Approaches

This study will see if a biosimilar of ustekinumab helps adults with mucocutaneous Behçet's syndrome who are refractory to or intolerant of standard treatments, compared with patients treated with apremilast.

Quick facts

• Study type: Observational
• Enrollment: 208 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Groupe français d'étude des Maladies Inflammatoires de loeil (Academic / other)
• Drugs / interventions: ustekinumab
• Locations: 11 sites (Bordeaux and 10 other locations)
• Trial ID: NCT07244614 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, observational cohort with parallel groups collecting routine clinical data on about 208 patients treated with either a ustekinumab biosimilar (n≈104) or apremilast (n≈104). Data are collected retrospectively and prospectively from regular care visits (baseline, week 4, 12, 24, 36 and 52) without additional study-specific visits or procedures. Clinical exams, lab results and disease activity scores (BDCAF, BSAS, PhGA) recorded in medical records will be used to compare outcomes and tolerability between the two cohorts. Inclusion targets adults meeting the 2013 Behçet's criteria with active mucocutaneous manifestations for the ustekinumab cohort and treatment-naïve mucocutaneous patients for the apremilast cohort.

Who should consider this trial

Good fit: Adults (≥18) who meet the 2013 international Behçet's criteria and have active mucocutaneous manifestations, either refractory/intolerant to colchicine/apremilast and receiving ustekinumab or treatment-naïve patients starting apremilast, are the intended participants.

Not a fit: Patients who are pregnant, under 18, without active mucocutaneous disease, or already well controlled on standard therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could provide real-world evidence that a ustekinumab biosimilar improves mucocutaneous symptoms and tolerability for patients not helped by conventional therapies.

How similar studies have performed: Case reports and small series have suggested ustekinumab can improve mucocutaneous Behçet's symptoms, but large comparative real-world data—especially for biosimilars—remain limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old;
* Non-opposition to study;
* Use of contraceptive measures;
* Fulfillment of the international classification criteria for Behçet's disease, revised in 2013;
* Indication for ustekinumab or apremilast within the standard of care of mucocutaneous Behçet's syndrome
* For ustekinumab cohort: Active mucocutaneous manifestations of Behçet's syndrome that are recurrent, intolerant or refractory to colchicine or apremilast, including oral ulcers, genital ulcers, skin lesions (e.g., pseudofolliculitis), and/or inflammatory arthralgia/arthritis.
* For apremilast cohort: recurrent active mucocutaneous manifestations of Behçet's syndrome naïve of treatment.

Due to its fluctuant characteristics over time, active oral ulcers are defined as two or more oral ulcers over the month preceding inclusion and must have occurred at least three times in the previous 12-month period, despite the previous use of colchicine

Exclusion Criteria:

* Pregnancy;
* Previous treatment failure to ustekinumab;
* Contraindications to ustekinumab, such as:
* Active chronic infections (e.g., active tuberculosis, replicative hepatitis B, HIV, etc.) or malignancies;
* Live vaccins in the past 3 months;
* Severe renal impairment (CrCl \<30mL/min/1,73m²)
* Severe hepatic impairment (transaminases 5 times the upper normal values)
* Severe cytopenias:

Platelets \< 50 x 103/mm3 Neutrophils \< 1000/mm3 Hemoglobin \< 8 g/Dl

Where this trial is running

Bordeaux and 10 other locations

• CHU BORDEAUX Hôpital Saint-André - Service de médecine interne — Bordeaux, France (Not_yet_recruiting)
• Service de médecine interne-APHP - Henri Mondor — Créteil, France (Not_yet_recruiting)
• HOPITAL CROIX-ROUSSE - HCL - service de médecine interne — Lyon, France (Not_yet_recruiting)
• Hospices civils de Lyon — Lyon, France (Not_yet_recruiting)
• GHSIF Melun — Melun, France (Recruiting)
• AP-HP-Hôpital COCHIN — Paris, France (Not_yet_recruiting)
• service de dermatologie - APHP - St Louis — Paris, France (Not_yet_recruiting)
• CHU Rouen_Hôpital Charles Nicolle — Rouen, France (Not_yet_recruiting)
• CHU de Rouen - service dermatologie — Rouen, France (Not_yet_recruiting)
• APHP_Hopital Lariboisière — Paris, Île-de-France Region, France (Active_not_recruiting)
• APHP_ Hôpital Pitié-Salpêtrière — Paris, Île-de-France Region, France (Recruiting)

Study contacts

• Study coordinator: DAVID SAADOUN, Professor

Conditions Behçet's Syndrome; Behçet's syndrome; biosimilar; ustekinumab; refractory; apremilast