Trials / Recruiting
RecruitingNCT04528082
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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 with Behçet's disease (BD) through week 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apremilast | Participants will receive apremilast orally. |
| DRUG | Placebo | Participants will receive the matching placebo orally. |
Timeline
- Start date
- 2021-09-09
- Primary completion
- 2030-02-07
- Completion
- 2030-12-17
- First posted
- 2020-08-27
- Last updated
- 2025-12-01
Locations
27 sites across 8 countries: France, Greece, Israel, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04528082. Inclusion in this directory is not an endorsement.