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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05565560

Enrollment

Registered

2022-10-04

Start date

2023-01-25

Completion date

2026-09-03

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis

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.

Interventions

DRUGApremilast

Oral tablets

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Contacts

STUDY_DIRECTORMD

Amgen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026