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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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 facts

Study ID

NCT03701763

Run by

Amgen

People needed

245

Starts

2018-12-19

Expected to finish

2023-03-27

Last updated by the study team

2024-12-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
• Subjects must have a weight of ≥ 20 kg
• Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
• Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
• PASI score ≥ 12; and
• Body surface area (BSA) ≥ 10%; and
• sPGA ≥ 3 (moderate to severe)
• Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
• Candidate for systemic therapy or phototherapy

You may not qualify if…

• Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
• Psoriasis flare or rebound within 4 weeks prior to Screening
• Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
• Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline
• Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis
• a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)
• Exceptions*:
• i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions
• Subjects should not use these topical treatments within 24 hours prior to the clinic visit.
• b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Johnson Dermatology Clinic — Fort Smith, Arkansas, United States
• Zenith Research Inc. — Beverly Hills, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Avance Clinical Trials — Laguna Niguel, California, United States
• Stanford University — Palo Alto, California, United States
• Coastal Family Dermatology — San Luis Obispo, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• California Dermatology Institute — Thousand Oaks, California, United States
• Solutions Through Advanced Research Inc — Jacksonville, Florida, United States
• Glick Skin Institute Clinical Research — Margate, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• Ciocca Dermatology — Miami, Florida, United States
• University of South Florida Health Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• Skin Care Physicians of Georgia — Macon, Georgia, United States
• Treasure Valley Medical Research — Meridian, Idaho, United States
• DeNova Research — Chicago, Illinois, United States
• Dawes Fretzin Dermatology Group Inc — Indianapolis, Indiana, United States
• Epiphany Dermatology of Kansas, LLC — Overland Park, Kansas, United States
• ActivMed Practices and Research Inc — Beverly, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• J Woodson Dermatology and Associates Ltd — Henderson, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Forest Hills Dermatology Group — Forest Hills, New York, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.