A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Trial Profile

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Dec 2016

At a glance

  • Drugs Apremilast (Primary)
  • Indications Plaque psoriasis; Pruritus
  • Focus Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 20 Dec 2016 According to a Celgene Corporation media release,Japan Ministry of Health, Labor and Welfare (MHLW) granted a full marketing authorisation to apremilast (Otezla) for the treatment of adult patients with plaque psoriasis based on data from this study and other three studies(ESTEEM-1 and 2, and PSOR-011).
    • 24 Mar 2016 Pooled post-hoc analysis of 3 trials (PSOR-005, ESTEEM-1 and ESTEEM-2) published in the Journal of the American Academy of Dermatology.
    • 20 Mar 2015 Pooled data (16-week palmoplantar analysis) from ESTEEM and PSOR-005 trials presented at the 73rd annual meeting of American Academy of Dermatology, according to a Celgene Corporation Media Release.
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