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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

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

    • Most Recent Events

    • 17 Oct 2023 Results assessing to conduct a placebo anchored matching-adjusted indirect comparison of endoscopic outcomes between upadacitinib and ustekinumab among patients with moderately to severely active CD from phase 3 UPA trials (NCT03105128, 03104413, 03105102) and UST endoscopy sub-studies (NCT01369329, 01369342, 01369355) from the phase 3 UNITI/IM-UNITI program, presented at the 31st United European Gastroenterology Week.
    • 27 Jun 2023 Results indirectly comparing efficacy of Risankizumab versus Ustekinumab using data from phase 3 trials (RZB: NCT03104413; NCT03105128; NCT03105102; UST: NCT01369329; NCT01369342; NCT01369355) for induction and maintenance treatment of moderately to severely active crohns disease, published in the Advances in Therapy.
    • 04 Mar 2023 Results published in the Janssen media release.
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