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

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.

Inclusion Criteria:

• 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 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