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

NCT04528082 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-01

No results posted yet for this study

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

  • Behçet Disease

Interventions

DRUG

Apremilast

Participants will receive apremilast orally.

DRUG

Placebo

Participants will receive the matching placebo orally.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2030-02-07
Completion
2030-12-17
FDA Drug
Yes

Countries

  • France
  • Greece
  • Israel
  • Italy
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528082 on ClinicalTrials.gov