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

ConditionBehçet Disease

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age2-17

SponsorAmgen

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).