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

Recruiting
6 - 17 years of age
Both
Phase 3

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Overview

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

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 details

Plaque Psoriasis

NCT05565560

Amgen

16 January 2025

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