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ClinicalTrial.gov Identifier : NCT03398135

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

    Status Not yet recruiting
    Related Conditions
    Ulcerative Colitis

Enrollment Details

760 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M16-066

Brief summary

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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.

Participant Attributes :
  • Male and Female
  • Ages 16 Years to 80 Years

Canada: 13

0
Calgary, AB
1
Edmonton, AB
2
Edmonton, AB
3
Edmonton, AB
4
New Westminster, BC
5
Victoria, BC
6
Halifax, NS
7
London, ON
8
North Bay, ON
9
Vaughan, ON
10
Greenfield Park, QC
11
Montreal, QC
12
Montreal, QC
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Triple (Participant / Investigator / Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

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

More on this trial

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