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NCT Number: NCT05565560

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya City University Hospital, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apremilast

Drug

Oral tablets

Other names: AMG 407, Otezla

Primary outcomes

  1. 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

    Time frame: Week 16

Secondary outcomes

  1. Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16

    Time frame: Baseline, Week 16

  2. Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16

    Time frame: Baseline, Week 16

  3. Percent change from baseline in total PASI score at Week 16

    Time frame: Baseline, Week 16

  4. Percent change from baseline in affected body surface area (BSA) at Week 16

    Time frame: Baseline, Week 16

  5. Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16

    Time frame: Week 16

  6. Change from baseline in CDLQI score at Week 16

    Time frame: Baseline, Week 16

  7. Number of participants with treatment-emergent adverse events

    Time frame: Approximately 52 weeks

  8. Number of participants with clinically significant changes in vital signs

    Time frame: Approximately 62 weeks

  9. Number of participants with clinically significant changes in laboratory abnormalities

    Time frame: Approximately 62 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2022
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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