Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease (NCT04528082) | Clinical Trial Compass
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
France, Greece60 participantsStarted 2021-09-09
Plain-language summary
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.
Who can participate
Age range2 Years – 17 Years
SexALL
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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).
What they're measuring
1
Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12)