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

Phase 3

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Apremilast

• Registration Number: NCT05565560
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-04
• Study Start: 2023-01-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-05-29
• Primary Completion: 2025-11-25
• Study Completion: 2026-09-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apremilast	Apremilast	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.

Primary Outcome Measures

Name	Time	Method
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16	Week 16

Secondary Outcome Measures

Name	Time	Method
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16	Baseline, Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16	Baseline, Week 16
Percent change from baseline in total PASI score at Week 16	Baseline, Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16	Baseline, Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16	Week 16
Change from baseline in CDLQI score at Week 16	Baseline, Week 16
Number of participants with treatment-emergent adverse events	Approximately 52 weeks
Number of participants with clinically significant changes in vital signs	Approximately 62 weeks
Number of participants with clinically significant changes in laboratory abnormalities	Approximately 62 weeks

Trial Locations

Locations (29)

Hospital of the University of Occupational and Environmental Health, Japan; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Nagoya City University Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kurume University Hospital; 🇯🇵 Kurume-shi, Fukuoka, Japan

Fukushima Medical University Hospital; 🇯🇵 Fukushima-shi, Fukushima, Japan

Gifu University Hospital; 🇯🇵 Gifu-shi, Gifu, Japan

Gunma University Hospital; 🇯🇵 Maebashi-shi, Gunma, Japan

Takagi Dermatological Clinic; 🇯🇵 Obihiro-shi, Hokkaido, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Kanazawa Medical University Hospital; 🇯🇵 Kahoku-gun, Ishikawa, Japan

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