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

Trial ID or NCT#

NCT03701763

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 6 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian2. Subjects must have a weight of ≥ 20 kg3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
    1. * PASI score ≥ 12; and * Body surface area (BSA) ≥ 10%; and * sPGA ≥ 3 (moderate to severe)5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
  1. 1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline2. Psoriasis flare or rebound within 4 weeks prior to Screening3. 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 consent4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis
    1. 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)
      1. Exceptions\*:
    2. 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
      1. \*Subjects should not use these topical treatments within 24 hours prior to the clinic visit.
  2. 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).
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Investigator(s)

Joyce Teng, MD, PhD
Joyce Teng, MD, PhD
Dermatologist, Pediatric dermatologist
Professor of Dermatology and, by courtesy, of Pediatrics

Contact us to find out if this trial is right for you.

Contact

Research Team @ Pediatric Dermatology
650-724-1982

View on ClinicalTrials.gov