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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospices Civils de Lyon Hopital Femme Mere Enfant
  Bron, France Recruiting
• Hopital Robert Debre
  Paris, France Recruiting
• Agia Sofia Children Hospital
  Athens, Greece Recruiting
• Attikon University General Hospital
  Athens, Greece Recruiting
• General Hospital of Thessaloniki Ippokrateio
  Thessaloniki, Greece Recruiting
• Meir Medical Center
  Kfar Saba, Israel Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.