Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

Sponsor
Amgen
Study ID
NCT04528082
Phase
PHASE3
Status
Recruiting
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Conditions

  • Behçet Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Participants will receive apremilast orally.
  • Placebo — DRUG
    Participants will receive the matching placebo orally.

Study Details

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.

Key Dates

First listed
Aug 27, 2020
Start date
Sep 9, 2021
Status verified
Nov 2025
Primary completion
Feb 7, 2030
Completion
Dec 17, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Participants will receive apremilast orally in the double-blind 12 week treatment phase. Then the participants will continue to receive apremilast in the active 40 weeks treatment phase.
  • Placebo Comparator: Placebo to Apremilast
    Participants will receive the matching placebo orally in the double-blind 12 week treatment phase. Then the participants will receive apremilast in the active 40 weeks treatment phase.

Primary Outcome Measure

Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12) [ Time Frame: Week 0 to Week 12 ]

Central Contacts