Behçet's Syndrome (BS)USBESTNCT07244614
Ustekinumab in BEhçet's Syndrome STudy
An observational study of Behçet's Syndrome (BS), run by Groupe français d'étude des Maladies Inflammatoires de loeil at 11 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behçet's Syndrome (BS)
- How many people
- 208 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Sep 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two groups will be established in this observational cohort: 1. Patients with active mucocutaneous manifestations of Behçet's syndrome that are either relapsing, refractory or intolerant to conventional treatments, that have received an indication of ustekinumab according to the standard of care of tertiary centres. 2. Patients with active mucocutaneous manifestations of Behçet's syndrome treated by apremilast within standard of care will be also retrospectively collected in order to establish a comparative group.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Severe hepatic impairment (transaminases 5 times the upper normal values)
- Severe cytopenias:
- Platelets < 50 x 103/mm3 Neutrophils < 1000/mm3 Hemoglobin < 8 g/Dl
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 10 recruiting
- Not yet recruiting
CHU BORDEAUX Hôpital Saint-André - Service de médecine interne
Bordeaux
Emmanuel RIBEIRO, MD, +33556795828, emmanuel.ribeiro@chu-bordeaux.fr
- Not yet recruiting
Service de médecine interne-APHP - Henri Mondor
Créteil, 94000
Nicolas LIMAL, Professor, +33149812076, nicolas.limal@aphp.fr
- Not yet recruiting
HOPITAL CROIX-ROUSSE - HCL - service de médecine interne
Lyon
Nicolas Fournier, MD, +33 4 26 73 26 36, nicolas.fournier01@chu-lyon.fr
- Not yet recruiting
Hospices civils de Lyon
Lyon
Cecile lesort, MD, +33472110321, cecile.lesort@chu-lyon.fr
- Recruiting
GHSIF Melun
Melun, 77000
Nabil BELFEKI, MD, +33181741818, nabil.belfeki@ghsif.fr
- Not yet recruiting
AP-HP-Hôpital COCHIN
Paris
Sarah Guegan, MD, +33158411809, sarah.guegan@aphp.fr
- Not yet recruiting
service de dermatologie - APHP - St Louis
Paris
Thibault Mahevas, MD, +33142499733, thibault.mahevas@aphp.fr
- Active, not recruiting
APHP_Hopital Lariboisière
Paris, Île-de-France Region, 75010
- Recruiting
APHP_ Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
David Saadoun, Professor, +33142178042, david.saadoun@aphp.fr
- Not yet recruiting
CHU Rouen_Hôpital Charles Nicolle
Rouen, 76000
Mathilde LECLERQ, MD, +332 32 88 73 96, Mathilde.Leclercq@chu-rouen.fr
- Not yet recruiting
CHU de Rouen - service dermatologie
Rouen
Vivien Hebert, MD, +332326841, Vivien.hebert@chu-rouen.fr
About this study
Official title: Observational Study Assessing the Biosimilar of Ustekinumab in Active Mucocutaneous Behçet's Syndrome Refractory or Intolerant to Conventional Approaches
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.
Read more
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.
Read the detailed description
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
- Conditions
- Behçet's Syndrome (BS)
- Keywords
- Behçet's syndrome, biosimilar, ustekinumab, refractory, apremilast
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab group | patients who have received the Ustekinumab | |
| Apremilast group | patients who have received the Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success at Week 24 will be defined as the absence of active mucocutaneous manifestations
Success at Week 24 will be defined as the absence of active mucocutaneous manifestations at week 24 without treatment discontinuation due to inefficacy or toxicity.
Measured: Week 24
Secondary outcomes (13)
Area under the curve (AUC) for the cumulative number of oral ulcers
Area under the curve (AUC) for the cumulative number of oral ulcers along the study period at W24.
Measured: Week 24
Duration (days) of oral and genital ulcers
Duration (days) of oral and genital ulcers up to W24
Measured: Week 24
Number of oral and genital ulcers
Number of oral and genital ulcers up to week 24
Measured: Week 24
Number of painful and swollen joints
Number of painful and swollen joints up to W24
Measured: Week 24
Rate of patients with complete response (ie, no mucocutaneous manifestations), partial response (>50% reduction in overall mucocutaneous manifestations), and no response
Rate of patients with complete response (ie, no mucocutaneous manifestations), partial response (>50% reduction in overall mucocutaneous manifestations), and no response (ie, persistence of mucocutaneous manifestations not fulfilling complete or partial response definitions) at W12 and W24
Measured: Week 12 and Week 24
Rate of treatment discontinuations for safety reasons
Rate of treatment discontinuations for safety reasons up to W24
Measured: Week 24
Rate of treatment failures
Rate of treatment failures (i.e., persistence of active mucocutaneous manifestations that require a change in immunomodulatory therapy) up to W24
Measured: Week 24
Change in BDCAF scores
The score is between 0 and 12. Higher scores indicate a worse evaluation
Measured: Week 24
Frequency and severity of adverse events
Frequency and severity of adverse events (CTCAE grade) along the study period.
Measured: 48 months
Safety of patients receiving the Apremilast
frequency and severity of adverse events in patients receiveing apremilast.
Measured: 48 months
pain intensity (0-10 EVA score) for genital and oral ulcers
pain intensity (0-10 EVA score) for genital and oral ulcers up to W24
Measured: WEEK24
Change in BSAS scores
The score is between 0 and 100. Higher scores indicate a worse evaluation
Measured: week24
Change PhGA scores
The score is between 0 and 10. Higher scores indicate a worse evaluation
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's Syndrome (BS)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244614
- Sponsor's protocol ID
- USBEST
- Other IDs
- 2025-A01077-42
- Acronym
- USBEST
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Assessing the Biosimilar of Ustekinumab in Active Mucocutaneous Behçet's Syndrome Refractory or Intolerant to Conventional Approaches
- ClinicalTrials.gov ID
- NCT07244614
- Acronym / sponsor ID
- USBEST / USBEST
- Conditions
- Behçet's Syndrome (BS)
- Keywords
- Behçet's syndrome, biosimilar, ustekinumab, refractory, apremilast
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeilUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ustekinumab group | – | –patients who have received the Ustekinumab |
| Apremilast group | – | –patients who have received the Apremilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups will be established in this observational cohort: 1. Patients with active mucocutaneous manifestations of Behçet's syndrome that are either relapsing, refractory or intolerant to conventional treatments, that have received an indication of ustekinumab according to the standard of care of tertiary centres. 2. Patients with active mucocutaneous manifestations of Behçet's syndrome treated by apremilast within standard of care will be also retrospectively collected in order to establish a comparative group.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success at Week 24 will be defined as the absence of active mucocutaneous manifestations
Time frame: Week 24
Success at Week 24 will be defined as the absence of active mucocutaneous manifestations at week 24 without treatment discontinuation due to inefficacy or toxicity.
13 secondary outcomes
Area under the curve (AUC) for the cumulative number of oral ulcers
Time frame: Week 24
Duration (days) of oral and genital ulcers
Time frame: Week 24
Number of oral and genital ulcers
Time frame: Week 24
Number of painful and swollen joints
Time frame: Week 24
Rate of patients with complete response (ie, no mucocutaneous manifestations), partial response (>50% reduction in overall mucocutaneous manifestations), and no response
Time frame: Week 12 and Week 24
Rate of treatment discontinuations for safety reasons
Time frame: Week 24
Rate of treatment failures
Time frame: Week 24
Change in BDCAF scores
Time frame: Week 24
Frequency and severity of adverse events
Time frame: 48 months
Safety of patients receiving the Apremilast
Time frame: 48 months
pain intensity (0-10 EVA score) for genital and oral ulcers
Time frame: WEEK24
Change in BSAS scores
Time frame: week24
Change PhGA scores
Time frame: week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet's Syndrome (BS), run by Groupe français d'étude des Maladies Inflammatoires de loeil at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAVID SAADOUN, Professor (+33142178042, david.saadoun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success at Week 24 will be defined as the absence of active mucocutaneous manifestations (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.