A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

Trial Profile

A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2017

At a glance

  • Drugs Tildrakizumab (Primary)
  • Indications Plaque psoriasis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms reSURFACE 1
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 13 Jun 2017 Results of two phase III studies (reSURFACE 1 and reSURFACE 2) published in the Internet Document.
    • 24 May 2017 According to a Sun Pharmaceutical Industries media release, the US FDA has accepted the Biologics License Application (BLA) for tildrakizumab for review. The application is based on data from reSURFACE 1 and 2 trials.
    • 24 Mar 2017 According an Almirall S.A. media release, company announced the validation of the Regulatory Filing of tildrakizumab with the European Medicines Agency (EMA). Regulatory filing includes data from reSURFACE 1 and 2 trials.
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