Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05565560
NCT05565560Active, not recruitingPhase 3

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

Amgen50 sites in 1 country17 target enrollmentStarted: January 25, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Sponsor
Amgen
Enrollment
17
Locations
50
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Apremilast

Experimental

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.

Intervention: Apremilast (Drug)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Amgen
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (50)

Loading locations...

Similar Trials

Completed
Phase 3
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's DiseaseBehçet's Syndrome
NCT02307513Amgen207
Completed
Phase 3
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic ArthritisPsoriatic Arthritis
NCT01172938Amgen504
Completed
Phase 3
PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic ArthritisPsoriatic Arthritis
NCT01212770Amgen505
Completed
Phase 3
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)Psoriatic Arthritis
NCT01307423Amgen529
Completed
Phase 3
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic ArthritisPsoriatic Arthritis
NCT01212757Amgen488