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

Last updated: February 13, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Lupus

Psoriatic Arthritis

Joint Injuries

Treatment

Apremilast

Clinical Study ID

NCT05767047
20190531
2022-003024-41
  • Ages 5-18
  • All Genders

Study Summary

The primary objective of this study is to evaluate the long-term safety of apremilast in participants 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent / assent obtained

  • Must have completed Week 52 on treatment on core study

  • Age and sex specific body mass index (BMI) no lower in range than the 5th percentileon Centers for Disease Control (CDC growth chart)

  • Willing to adhere to study visit schedule and protocol requirements

  • Must have acceptable benefit/risk for continued treatment with apremilast

Exclusion

Exclusion Criteria:

  • Answer "yes" to any question on C-SSRS at Week 52 visit of core study

  • Scheduled surgery or other interventions that would interrupt study participation

  • Female participants of childbearing potential unwilling to use protocol specifiedmethod of contraception during treatment and for 30 days after last dose

  • Female participants planning to become pregnant while on study through 30 days afterlast dose

  • Female participants of childbearing potential with positive pregnancy test at Week 0

  • Known sensitivity to any products to be administered during dosing

  • Not likely to be available to complete all protocol-required study visits

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Apremilast
Phase: 3
Study Start date:
March 23, 2023
Estimated Completion Date:
December 30, 2032

Connect with a study center

  • General Hospital of Thessaloniki Ippokrateio

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, Comunidad Valenciana 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Umraniye Egitim ve Arastirma Hastanesi

    Istanbul, 34764
    Turkey

    Active - Recruiting

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