Status:
RECRUITING
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Lead Sponsor:
Amgen
Conditions:
Behçet Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04528082
Start Date
September 9 2021
End Date
December 17 2030
Last Update
December 1 2025
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France, 69677
2
Hopital Necker Enfants Malades
Paris, France, 75015
3
Hopital Robert Debre
Paris, France, 75019
4
Agia Sofia Children Hospital
Athens, Greece, 11527