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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2017

At a glance

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

    • 01 Nov 2017 Results assessing exposure response presented at the 25th United European Gastroenterology Week.
    • 03 Oct 2017 Planned End Date changed from 19 Oct 2019 to 21 Oct 2019.
    • 17 Jun 2017 Integrated safety results from 3 psoriatic arthritis , 5 Crohns disease, & 4 psoriasis trials presented at the 18th Annual Congress of the European League Against Rheumatism
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