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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: 24 Apr 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

    • 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
    • 14 Nov 2023 Status changed from completed to discontinued.
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