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A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

NCT05565560•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 17 years

Sex

ALL

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

Locations (29)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Takagi Dermatological Clinic

Obihiro-shi, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kanazawa Medical University Hospital

Kahoku-gun, Ishikawa-ken, Japan

Key Dates

Start Date

January 25, 2023

Primary Completion Date

November 20, 2025

Completion Date

September 6, 2026

Last Updated

December 19, 2025

Enrollment

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

Apremilast

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

View study

RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis