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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 of Age with Moderate to Severe Plaque Psoriasis

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Trial Profile

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 of Age with Moderate to Severe Plaque Psoriasis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 22 Aug 2024

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At a glance

  • Drugs Apremilast (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms SPROUT
  • Sponsors Amgen; Celgene Corporation

    • Most Recent Events

    • 20 Aug 2024 According to an Amgen media release, earlier this year, U.S. Food and Drug Administration (FDA) approved Otezla for the treatment of moderate to severe plaque psoriasis in children and adolescents ages 6 and older who weigh at least 20 kg (44 lb) and are candidates for phototherapy or systemic therapy based on results from SPROUT and Otezla (apremilast) is now available in the U.S. for pediatric use.
    • 12 Mar 2024 Results assessing efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis at 52 weeks, presented at the American Academy of Dermatology annual Meeting 2024.
    • 12 Mar 2024 According to an Amgen media release, the company announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego

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