Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Cheaper version of ustekinumab tested for painful Behçet's ulcers

NCT ID NCT07244614

Disease control Sponsor: Groupe français d'étude des Maladies Inflammatoires de loeil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is observing 208 adults with Behçet's syndrome who have painful mouth and genital ulcers that did not improve with standard treatments. Researchers are tracking how well a biosimilar (a copy) of the drug ustekinumab controls these ulcers over 24 weeks, and comparing results to patients taking another drug called apremilast. No extra tests or visits are added—just routine care data is collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
biosimilar of ustekinumab
What this could lead to
If successful, this could show that a more affordable biosimilar version of ustekinumab is effective for controlling painful mouth and genital ulcers in Behçet's syndrome.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. The biosimilar may not work as well as the original drug, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 208 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Behçet's syndrome (BS) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Behcet disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Behçet's syndrome (BS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP-Hôpital COCHIN

    NOT_YET_RECRUITING

    Paris, France

  • APHP_ Hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, Île-de-France Region, 75013, France

  • APHP_Hopital Lariboisière

    ACTIVE_NOT_RECRUITING

    Paris, Île-de-France Region, 75010, France

  • CHU BORDEAUX Hôpital Saint-André - Service de médecine interne

    NOT_YET_RECRUITING

    Bordeaux, France

  • CHU Rouen_Hôpital Charles Nicolle

    NOT_YET_RECRUITING

    Rouen, 76000, France

  • CHU de Rouen - service dermatologie

    NOT_YET_RECRUITING

    Rouen, France

  • GHSIF Melun

    RECRUITING

    Melun, 77000, France

  • HOPITAL CROIX-ROUSSE - HCL - service de médecine interne

    NOT_YET_RECRUITING

    Lyon, France

  • Hospices civils de Lyon

    NOT_YET_RECRUITING

    Lyon, France

  • Service de médecine interne-APHP - Henri Mondor

    NOT_YET_RECRUITING

    Créteil, 94000, France

  • service de dermatologie - APHP - St Louis

    NOT_YET_RECRUITING

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.