ClinicaliQ Trial Snapshot
- Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet’s Disease — Recruiting • Phase III • Cardiology / Cardiovascular • NCT04528082.
- Intervention tested: Apremilast (a phosphodiesterase-4 inhibitor) versus placebo for treating oral ulcers in children with Behçet's disease, addressing a significant unmet need in pediatric BD management where oral manifestations are often the first clinical feature.
- Patient eligibility: Children aged 2 to <18 years with active oral ulcers attributed to Behçet's disease; this represents a previously under-studied population in oral ulcer treatment trials, filling an important evidence gap in pediatric rheumatology.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.