Summary

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

Description

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.

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 Colitis, Ulcerative Ulcer Antibodies, Monoclonal risankizumab Substudy 1: Double-blind Risankizumab Dose 1 Substudy 1: Double-blind Risankizumab Dose 2 Substudy 2: Open-label Risankizumab Dose 1 Substudy 2: Open-label Risankizumab Dose 2 Substudy 3: Open-label Extension Risankizumab

Eligibility

You can join if…

Open to people ages 16-80

  • Participants who have completed Study M16-065 or Study M16-067 and have achieved clinical response as defined in the protocol

You CAN'T join if...

  • Participants 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 participant unsuitable for this study
  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Participant 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 /ID# 201209 accepting new patients
    San Francisco California 94115-3011 United States
  • Kaiser Permanente - San Francisco /ID# 212087 not yet accepting patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT03398135
Phase
Phase 3
Study Type
Interventional
Last Updated