Actively Recruiting

Phase 3
Age: 5Years - 18Years
All Genders
NCT05767047

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Led by Amgen · Updated on 2025-12-01

48

Participants Needed

7

Research Sites

677 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.

CONDITIONS

Official Title

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Who Can Participate

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent or assent obtained
  • Completed 52 weeks of treatment in the core study
  • Under 18 years old at time of consent
  • Age- and sex-specific BMI at or above the 5th percentile per CDC growth charts
  • Willing to follow study visit schedule and protocol
  • Considered to have acceptable benefit/risk for continued apremilast treatment
Not Eligible

You will not qualify if you...

  • Positive response to any question on the Columbia-Suicide Severity Rating Scale at Week 52 of the core study
  • Scheduled surgery or other interventions that would disrupt study participation
  • Female participants of childbearing potential unwilling to use required contraception during treatment and 30 days after last dose
  • Female participants planning pregnancy during the study or within 30 days after last dose
  • Female participants with a positive pregnancy test at Week 0
  • Known sensitivity to any study products administered during dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, Greece, 54642

Actively Recruiting

2

Meir Medical Center

Kfar Saba, Israel, 4428164

Actively Recruiting

3

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain, 46026

Actively Recruiting

4

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

5

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye), 06100

Actively Recruiting

6

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye), 34098

Actively Recruiting

7

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye), 34764

Actively Recruiting

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Research Team

A

Amgen Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

1

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