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

Recruiting
5 - 18 years of age
Both
Phase 3

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Overview

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

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

Study details

Behçet's Disease, Juvenile Psoriatic Arthritis

NCT05767047

Amgen

4 February 2025

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