ClinicalTrials.gov record NCT07244614

Ustekinumab in BEhçet's Syndrome STudy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 16, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects medical-record data on people with mucocutaneous Behçet's syndrome who receive a biosimilar of ustekinumab in routine care, and uses a retrospective apremilast group for comparison. No extra visits or tests are added; available data from routine visits (including baseline and visits around weeks 4, 12, 24, 36 and 52 when recorded) are entered into an electronic case report form. The study measures clinical outcomes at Week 24 and tracks adverse events and other outcomes up to longer follow-up.

What it is studying. Whether and how patients receiving a biosimilar ustekinumab do, in routine care, regarding absence of active mucocutaneous manifestations and other clinical outcomes compared with patients receiving apremilast.

What the researchers hope to learn. To describe the clinical outcomes of a ustekinumab biosimilar in people with active mucocutaneous Behçet's syndrome who are relapsing, intolerant, or refractory to conventional treatments, and to compare those outcomes with a group receiving apremilast. Key measured outcomes include success at Week 24 (absence of active mucocutaneous manifestations), counts and duration of oral and genital ulcers, joint symptoms, response rates, treatment discontinuations and failures, changes in disease activity scores (BDCAF, BSAS, PhGA), and frequency/severity of adverse events over the study period.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This non-interventional study is an observational cohort with parallel groups aiming primarily to describe the success of biosimilar of ustekinumab in Behçet's syndrome in whom conventional approaches have failed or are not suitable well tolerated, and then to compare with patients receiving apremilast within routine care. Ustekinumab previously prescribed subcutaneously at 90 mg on Week 0, 4, 12 and 20 within the standard of care. Following non-opposition to participate, patients data will be collected, which will comprise data of the 3-month interval medical visits, except for the first month of treatment, in which the short-term tolerance of treatments is usually assessed (ie, baseline visit, then week 4, 12, 24, 36 and 52). Clinical examination, biological tests and relevant clinical scores (BDCAF, BSAS and PhGA) data that were performed within routine care. No changes to patients' usual care will be made (no additional visits, additional examinations or questionnaires), their safety and well-being remaining therefore unchanged. Data will be collected from the participant's medical record (containing medical reports and examinations, biological tests, nursing records, etc.), for the period of participation in the research, with the only purpose of meeting the objectives of the research. Data will be collected using an electronic 'eCRF observation book on the REDCap platform. The following data will be collected: demographic data (age, sex, weight, height); clinical data (history of the disease, pathology diagnosed, activity of the pathology), treatments, biological data, adverse events. No genetic data will be collected as part of the study. No data will be transferred abroad. No additional questionnaires, examinations or visits will be added by the research. Activity indexes for BS will be calculated as part of routine care. The number, duration and intensity of oral ulcers of patients will be verified by the nurse or the site investigator according to the routine care. Patients' data with active mucocutaneous Behçet's manifestations with an indication of starting apremilast within standard of care (according to AMM and PNDS) will be retrospectively collected in order to establish a retrospective cohort for comparative purposes.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

This non-interventional study is an observational and comparative cohort aiming to describe the success of biosimilar of ustekinumab in Behçet's syndrome in whom conventional approaches have failed or are not suitable well tolerated. Data on 208 patients is expected to be identified as follows:

  • data of 104 patients will be collected from patients who have received the ustekinumab
  • data of 104 patients will be collected from patients who have received the apremilast.

Ustekinumab is usually prescribed subcutaneously at 90 mg on Week 0, 4, 12 and 20 within the standard of care. Following non-opposition to participate, patients data will be collected retrospectively according to local clinical practices and usual care, which usually comprises 3-month interval medical visits, except for the first month of treatment, in which the short-term tolerance of treatments is usually assessed (ie, baseline visit, then week 4, 12, 24, 36 and 52). Available data on clinical examination, biological tests and relevant clinical scores (BDCAF, BSAS and PhGA) that are performed within routine care will be retrieved. No changes to patients' usual care will be made (no additional visits, additional examinations or questionnaires), their safety and well-being remaining therefore unchanged. Data will be collected from the participant's medical record (containing medical reports and examinations, biological tests, nursing records, etc.), for the period of participation in the research, with the only purpose of meeting the objectives of the research. Data will be collected using an electronic eCRF observation book on the REDCap platform. The following data will be collected: demographic data (age, sex, weight, height); clinical data (history of the disease, pathology diagnosed, activity of the pathology), treatments, biological data, adverse events. No genetic data will be collected as part of the study. No data will be transferred abroad. No additional questionnaires, examinations or visits will be added by the research. Activity indexes for BS are usually calculated as part of routine care. The number, duration and intensity of oral ulcers of patients might be verified by the nurse or the site investigator according to the routine care. Patients data with active mucocutaneous Behçet's manifestations with an indication of starting apremilast within standard of care will be also retrospectively collected in order to establish a comparative group, using the same parameters above mentioned

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you take part, the study team will collect information from your medical record about the routine clinic visits and tests done while you receive treatment for mucocutaneous Behçet's syndrome. They will use data recorded at the usual visits (baseline, Week 4, 12, 24, 36 and 52) including clinical examination findings, routine blood tests, treatments, and disease activity scores (BDCAF, BSAS and PhGA); nurses or site investigators may verify the number, duration, intensity and pain of oral ulcers as done in routine care. No extra visits, examinations, or questionnaires will be added, and no genetic data will be collected; information will be entered into an electronic database (REDCap). For comparison, data from people treated with apremilast will be collected retrospectively, and adverse events may be followed in records for up to 48 months.

How the study is structured. An observational, comparative cohort (case‑control style) using routine medical-record data. Two groups are recorded: patients treated with a ustekinumab biosimilar and a retrospective group treated with apremilast. The study does not add visits or procedures; routinely collected clinical exams, lab results, and disease activity scores are retrieved and entered into an electronic database.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Behçet's disease

This trial is also listed on this site under familial Mediterranean fever.

Clinical trials34 trials listed for Behçet's diseaseEvery trial the registry lists for Behçet's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Behçet's disease researchLatest monthly update: September 2026. Includes: Low-dose IL-2 trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2025
Primary completion
Apr 30, 2026 (estimated)
Study completion
Dec 31, 2029 (estimated)
Target enrollment
208 participants (estimated)
Last updated on registry
Nov 24, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Groupe français d'étude des Maladies Inflammatoires de loeil

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (11)

Terms used on this page · explanations by MedicalUpdates.ai

parallel groups
Participants are divided into two or more groups, and each group receives a different intervention at the same time, so the groups can be compared.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
retrospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
CrCl
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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