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

  • STATUS
    Recruiting
  • End date
    Oct 19, 2022
  • participants needed
    230
  • sponsor
    Amgen
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Updated on 16 December 2020
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Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Universitatsklinikum Erlangen (9.5 mi away) Contact
+191 other location
systemic therapy
phototherapy
topical agents
cc-10004
apremilast
plaque psoriasis

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.

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.

Details
Treatment Placebo, Apremilast (CC-10004)
Clinical Study IdentifierNCT03701763
SponsorAmgen
Last Modified on16 December 2020

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Eligibility

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Inclusion Criteria

Is your age between 6 yrs and 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Psoriasis and Psoriatic Disorders or Psoriasis?
Do you have any of these conditions: Psoriasis or Psoriasis and Psoriatic Disorders?
Do you have any of these conditions: Psoriasis and Psoriatic Disorders or Psoriasis?
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

Exclusion Criteria

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
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
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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