Summary

for people ages 16-80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab 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 subjects who completed Substudy 1 or 2.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

Keywords

Ulcerative Colitis (UC) ABBV-066 BI 655066 Colitis Ulcer Colitis, Ulcerative risankizumab Substudy 2: Open-label Risankizumab Dose 1 Substudy 1: Double-blind Risankizumab Dose 2 Substudy 2: Open-label Risankizumab Dose 2 Substudy 3: Open-label Extension Risankizumab Substudy 1: Double-blind Risankizumab Dose 1

Eligibility

You can join if…

Open to people ages 16-80

  • Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response

You CAN'T join if...

  • Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study
  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067

Locations

  • UCSF Center for Colitis and Crohn's Disease not yet accepting patients
    San Francisco California 94115-3011 United States
  • Univ of California San Francis not yet accepting patients
    San Francisco California 94158 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03398135
Phase
Phase 3
Study Type
Interventional
Last Updated
April 27, 2018