Last updated on July 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03701763

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Phoenix Childrens Hospital

Phoenix, AZ United States
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Johnson Dermatology Clinic

Fort Smith, AR United States
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Zenith Research, Inc.

Beverly Hills, CA United States
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First OC Dermatology

Fountain Valley, CA United States
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Stanford University

Palo Alto, CA United States
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Coastal Family Dermatology

San Luis Obispo, CA United States
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Mosaic Dermatology

Santa Monica, CA United States
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Ronald Reagan UCLA Medical Center

Santa Monica, CA United States
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California Dermatology Institute

Thousand Oaks, CA United States
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Ciocca Dermatology

Miami, FL United States
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Mayo Clinic

Rochester, MN United States
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Forest Hills Dermatology Group

Forest Hills, NY United States
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Wright State Physicians

Fairborn, OH United States
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Driscoll Children's Hospital

Corpus Christi, TX United States
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Texas Children's Hospital

Houston, TX United States
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Jordan Valley Dermatology Center

West Jordan, UT United States
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Karma Clinical Trials

Saint John's, NL Canada
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CHU Saint-Justine

Montreal, QC Canada
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AvantDerm

Toronto, Canada
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Hotel Dieu CHU Nantes

Nantes Cedex 01, France
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Hopital Necker

Paris Cedex 15, France
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Altai State Medical University

Barnaul, Russian Federation
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LLC Medical Center Zdorovaya Semiya

Novosibirsk, Russian Federation
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OOO Kurator

Saint Petersburg, Russian Federation
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Yarosavl State Medical Academy

Yaroslavl, Russian Federation
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Recruitment Status: Open


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