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).
Trial design
Treatments tested in this trial
- Apremilast
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
27France
Hospices Civils de Lyon Hopital Femme Mere Enfant69677, Bron France
Hopital Necker Enfants Malades75015, Paris France
Hopital Robert Debre75019, Paris France
Greece
Agia Sofia Children Hospital11527, Athens Greece
Sponsors and collaborators
Amgen
Lead sponsor
Source ClinicalTrials.gov