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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 Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

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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 Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITI-1
  • 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.
  • 26 Oct 2022 Results of pooled analysis from UNITI or IM-UNITI trials assessing the relationship between hospitalization and surgery rates and health state over one year in patients with CD presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022

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