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: 13 Oct 2017

At a glance

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

    • 13 Oct 2017 According to a Janssen Biotech media release, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
    • 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.
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