A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

  • STATUS
    Not Recruiting
  • End date
    Nov 7, 2023
  • participants needed
    760
  • sponsor
    AbbVie
Updated on 16 June 2021

Summary

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment risankizumab, placebo for risankizumab
Clinical Study IdentifierNCT03398135
SponsorAbbVie
Last Modified on16 June 2021

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