NCT03701763

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

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment will be assigned by weight with subjects 20 kg to \< 50 kg receiving apremilast 20 mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast (CC-10004)	Apremilast (CC-10004)
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-12-19
• Primary completion: 2022-04-25
• Completion: 2023-03-27
• First posted: 2018-10-10
• Last updated: 2024-12-16
• Results posted: 2023-12-07

Locations

99 sites across 10 countries: United States, Belgium, Canada, Czechia, France, Israel, Italy, Netherlands, Russia, Spain

Regulatory

• FDA-regulated drug study