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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apremilast<br>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. | Drug: Apremilast<br>* Oral tablets<br>* Other names: Otezla;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis