A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis

• Status: Not yet recruiting
• Trial end date: 2026-05-24
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.

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

Details

• Lead Sponsor: Amgen
• Treatments: Apremilast

Criteria

Inclusion Criteria:

• Japanese participants aged 6 to 17 years at screening

• Participants must have a weight of ≥ 15 kg

• Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening

• Has moderate to severe plaque psoriasis at screening and baseline as defined by:

• PASI score ≥ 12; and

• BSA ≥ 10; and

• sPGA ≥ 3 (moderate to severe)

• Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis

• Candidate for systemic therapy or phototherapy

Exclusion Criteria:

• Psoriasis flare or rebound within 4 weeks prior to screening

• Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments

• Other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease

• Prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent

• Guttate, erythrodermic, or pustular psoriasis at screening and baseline