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Treatment of oral ulcers in children with Behçet's disease using apremilast

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)

PHASE3 · Amgen · NCT04528082

This study is testing if a medication called apremilast can help children with Behçet's disease feel better by reducing their painful mouth sores.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment60 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorAmgen (industry)
Locations27 sites (Bron and 26 other locations)
Trial IDNCT04528082 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of apremilast compared to a placebo in treating oral ulcers in pediatric patients aged 2 to less than 18 years who have been diagnosed with Behçet's disease. The study will assess the reduction in the frequency and severity of oral ulcers over a 12-week period. Participants must have experienced multiple oral ulcers in the past year and have had prior treatment for their condition. The trial is designed to provide insights into the safety and efficacy of apremilast in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 2 to less than 18 years with a confirmed diagnosis of Behçet's disease and a history of recurrent oral ulcers.

Not a fit: Patients with major organ involvement or severe manifestations of Behçet's disease that require immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for children suffering from painful oral ulcers associated with Behçet's disease.

How similar studies have performed: While there have been studies on Behçet's disease treatments, the specific use of apremilast in pediatric patients for oral ulcers is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria

* Male or Female participants 2 to \< 18 years of age at randomization.
* Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.
* Oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit.
* Participant must have ≥ 2 oral ulcers at both the screening visit and on day 1.
* Participant has had prior treatment with ≥ 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.

Key Exclusion Criteria

* Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), or CNS (eg, meningoencephalitis) manifestations, or ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:

  * Previous major organ involvement is allowed if it occurred ≥1 year prior to the screening visit and is not active at time of enrollment
  * Participants with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed
  * Participants with BD-related arthritis and BD-skin manifestations are also allowed.
* Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).

Where this trial is running

Bron and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Behçet Disease, Behçet's Disease, Oral ulcers, Apremilast

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.