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

RecruitingPhase 3Ages 2 Years - 17 YearsAllAmgen
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • Apremilast
  • Placebo
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Where

27 sites
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France
Hopital Necker Enfants Malades
Paris, France
Hopital Robert Debre
Paris, France
Agia Sofia Children Hospital
Athens, Greece
Attikon University General Hospital
Athens, Greece
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece
Meir Medical Center
Kfar Saba, Israel
Ospedale Santissima Annunziata
Chieti, Italy

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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