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

• Status: Not yet recruiting
• Trial end date: 2032-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Apremilast

Criteria

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