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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT05565560

20200346

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Apremilast

Experimental group

Description:

Participants with a weight between ≥ 15 kg to \< 50 kg will receive apremilast 20 mg twice daily (BID) tablet. Participants weighing ≥ 50 kg will receive apremilast 30 mg BID tablet.

Treatment:

Drug: Apremilast