Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

Trial Profile

Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Dec 2016

At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms CADMUS
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 16 Dec 2016 According to a Janssen media release, company has submitted a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis, based on data from this trial.
    • 13 Jan 2016 According to a Janssen media release, Health Canada has approved ustekinumab (STELARA) for the treatment of chronic moderate-to-severe plaque psoriasis in adolescent patients (12 to 17 years) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies, based on data from this trial.
    • 07 Aug 2015 Results published in the Journal of the American Academy of Dermatology.
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