NCT03398135

A Study to Assess the Efficacy and Safety of an Active Drug in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

Brief summary

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

Interventional study

Status:
Enrolling by invitation
Conditions:
Ulcerative Colitis (UC)
Enrollment:
942 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-066
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 16 Years to 80 Years.

Inclusion Criteria:

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

Exclusion Criteria:

- 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 M16-067 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 M16-067.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5R 1W2
New Westminster - V3L 3W4
Victoria - V8V 3M9
Halifax - B3K 6R8
London - N6A 5W9
North Bay - P1B 2H3
Vaughan - L4L 4Y7
Levis - G6V 3Z1
Montreal - H1T 2M4
Montréal - H3G 1A4