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

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Apremilast (CC-10004) — DRUG
  Apremilast (CC-10004)
• Placebo — OTHER
  Placebo

Study Details

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.

Key Dates

First listed

Oct 10, 2018

Start date

Dec 19, 2018

Status verified

Dec 2024

Primary completion

Apr 25, 2022

Completion

Mar 27, 2023

Study Design

Enrollment

245 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Administration of Apremilast (CC-10004) - 20mg
  Apremilast 20mg Twice Daily (BID)
• Experimental: Administration of Apremilast (CC-10004) - 30mg
  Apremilast 30mg Twice Daily (BID)
• Placebo Comparator: Administration of Placebo
  Placebo tablet Twice Daily (BID)

Primary Outcome Measure

Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 [ Time Frame: Baseline to Week 16 ]

Locations (39)

Find similar trials in Birmingham, AL

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