Overview
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
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).