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RecruitingPhase 3NCT05767047

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

A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis

Sponsor

Amgen

Enrollment

48 participants

Start Date

Mar 23, 2023

Study Type

INTERVENTIONAL

Conditions

Juvenile Psoriatic ArthritisBehçet's Disease

Summary

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.

Eligibility

Min Age: 5 YearsMax Age: 18 Years

Inclusion Criteria5

  • Informed consent / assent obtained
  • Must have completed Week 52 on treatment on core study and must be \< 18 years of age at the time the informed consent document is signed
  • Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
  • Willing to adhere to study visit schedule and protocol requirements
  • Must have acceptable benefit/risk for continued treatment with apremilast

Exclusion Criteria6

  • 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 specified method of contraception during treatment and for 30 days after last dose
  • Female participants planning to become pregnant while on study through 30 days after last dose
  • Female participants of childbearing potential with positive pregnancy test at Week 0
  • Known sensitivity to any products to be administered during dosing
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Interventions

DRUGApremilast

Oral tablets or liquid suspension

Locations(7)

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, Greece

Meir Medical Center

Kfar Saba, Israel

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye)

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

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NCT05767047

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