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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Juvenile Psoriatic Arthritis; Behçet's Disease

Treatments: Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT05767047

20190531

2023-503433-21 (Other Identifier)

2022-003024-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Apremilast

Experimental group

Description:

Participants with a weight between ≥ 12 kg to \< 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to \< 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.

Treatment:

Drug: Apremilast