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ClinicalTrial.gov Identifier : NCT03105102

A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 

    Status Recruiting
    Related Conditions
    Crohn's Disease

Enrollment Details

912 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M16-000

Brief summary

Top

The study consists of 3 sub-studies, as follows:

  •  Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991
  • Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to induction treatment in Study M16-006 or Study M15-991;
  • Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in subjects who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989.

 

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

Canada: 19

0
Calgary, AB
1
Edmonton, AB
2
Edmonton, AB
3
Edmonton, AB
4
New Westminster, BC
5
Vancouver, BC
6
Victoria, BC
7
Halifax, NS
8
Halifax, NS
9
London, ON
10
North Bay, ON
11
Sudbury, ON
12
Toronto, ON
13
Vaughan, ON
14
Greenfield Park, QC
15
Montreal, QC
16
Montreal, QC
17
Montreal, QC
18
Hamilton, ON
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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

    Double (Participant/Investigator)

  • 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 entered and completed Study M16-006 or Study M15-991 or Study M15-989. 
    • Subjects have completed the study M16-006 or M15-991 and have achieved clinical response.
    • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
    • Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the subject unsuitable for this study.
    • Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
    • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989. 
    • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.