ClinicalTrials.gov record NCT04528082

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age2 years old to 17 years old
SexAll
LocationFrance, Greece, Israel, Italy, Spain, Switzerland, Turkey, United Kingdom
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 Phase 3, randomized, double-blind, placebo-controlled trial studies apremilast in children 2 to <18 years with active oral ulcers associated with Behçet's disease. Participants receive apremilast or matching placebo by mouth for a 12-week blinded period, then all participants receive apremilast during a 40-week active treatment phase. The study tracks oral ulcer counts, pain, disease activity, safety, and growth/puberty measures.

What it is studying. It compares oral apremilast with placebo to evaluate effects on oral ulcers and safety in children with Behçet's disease.

What the researchers hope to learn. To estimate apremilast's effects on the number and pain of oral ulcers compared with placebo through Week 12; to measure complete response rates for oral and genital ulcers; to assess changes in disease activity and quality-of-life measures; to monitor safety and adverse events (including suicide-related assessments) up to Week 56; and to collect data on growth, Tanner staging, body measurements, plasma drug concentrations, and taste/acceptability.

What this study is about

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

The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Apremilast
  • Placebo

Eligibility

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

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).

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

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.

Participants are randomized to take oral apremilast or matching placebo for a 12-week double-blind period, then all participants receive apremilast for a 40-week active treatment phase (total safety follow-up to about Week 56). Visits include regular oral exams to count and document ulcers, pain ratings (visual analog scale), disease-activity questionnaires (BDCAF), a child health survey (SF-10), and assessments of genital ulcers when applicable. Safety monitoring includes physical exams, growth and Tanner staging checks, blood samples (including apremilast plasma levels), recording of adverse events, and repeated screening for suicidal ideation using the Columbia Suicide Severity Rating Scale; a taste/acceptability questionnaire is done around Week 0 and Week 2. Participation involves multiple clinic visits, taking oral study medication as instructed, and routine blood draws and questionnaires.

How the study is structured. Phase 3 interventional drug study. Children are randomized to apremilast or matching placebo for a 12-week double-blind period (participants, caregivers, investigators, and outcome assessors masked). After week 12, all participants enter a 40-week active treatment phase receiving apremilast. The study measures ulcer counts and pain, disease activity scores, safety events (including suicidal ideation/behavior), and growth and pubertal development.

Questions you could ask

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

  • The registry lists this study under Behçet Disease. Does it apply to my diagnosis?
  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in France, Greece, Israel, Italy, Spain, Switzerland, Turkey, United Kingdom. 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 familial Mediterranean fever

This trial is also listed on this site under Behçet's disease.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 9, 2021
Primary completion
Feb 7, 2030 (estimated)
Study completion
Dec 17, 2030 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Dec 1, 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
Amgen

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 (27)

  • Hospices Civils de Lyon Hopital Femme Mere EnfantRecruiting

    Bron, 69677 · France

  • Hopital Necker Enfants MaladesTerminated

    Paris, 75015 · France

  • Hopital Robert DebreRecruiting

    Paris, 75019 · France

  • Agia Sofia Children HospitalRecruiting

    Athens, 11527 · Greece

  • Attikon University General HospitalRecruiting

    Athens, 12462 · Greece

  • General Hospital of Thessaloniki IppokrateioRecruiting

    Thessaloniki, 54642 · Greece

  • Meir Medical CenterRecruiting

    Kfar Saba, 4428164 · Israel

  • Ospedale Santissima AnnunziataRecruiting

    Chieti, 66100 · Italy

  • IRCCS Istituto Giannina GasliniRecruiting

    Genova, 16147 · Italy

  • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano PiniRecruiting

    Milan, 20122 · Italy

Terms used on this page · explanations by MedicalUpdates.ai

placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
screening visit
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
prior treatment
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Key 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.
Key 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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