A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2).

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2).

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2018

At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITI-2
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 14 Jun 2018 Results of a post hoc pooled analysis (NCT01369355, NCT01369342 and NCT01369329) published in the Gastroenterology
    • 31 Jan 2018 Results reporting on ustekinumab pharmacokinetics (PK) and exposure-response (ER) relationships using data derived from previously reported Phase 3 induction and maintenance studies in Crohns Disease (NCT01369329 (UNITI 1), NCT01369342 (UNITI 2), and NCT01369355 (IM UNITI)) published in the Gastroenterology
    • 01 Nov 2017 Results (n=458) assessing response and remission rates from UNITI-1 and UNITI-2 trials, presented at the 25th United European Gastroenterology Week.
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