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Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

NCT03701763 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2024-12-16

Study results available
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Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

Conditions

Interventions

DRUG

Apremilast (CC-10004)

Apremilast (CC-10004)

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2022-04-25
Completion
2023-03-27
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Israel
  • Italy
  • Netherlands
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701763 on ClinicalTrials.gov