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:
Recruiting
Conditions:
Ulcerative Colitis (UC)
Enrollment:
760 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 M16-065 or 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 M16-065 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

All the cities where the clinical studies are located

Calgary - T2N 4Z6

Edmonton - T5R 1W2

Edmonton - T6G 2X8

Edmonton - T6L 6K3

New Westminster - V3L 3W4

Victoria - V8V 3M9

Halifax - B3K 6R8

London - N6A 5A5

North Bay - P1B 2H3

Vaughan - L4L 4Y7

Levis - G6V 3Z1

Montréal - H1T 2M4

Montréal - H3G 1A4