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ClinicalTrial.gov Identifier : NCT03105128

A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

    Status Recruiting
    Related Conditions
    Crohn's Disease

Enrollment Details

855 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M16-006

Brief summary

Top

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn's disease (CD).

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

Canada: 18

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
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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 Blind (Subject, 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

    • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
    • Diagnosis of CD for at least 3 months prior to Baseline
    • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
    • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
    • If female, subject must meet the contraception recommendations
    • Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
    • Subjects with unstable doses of concomitant Crohn's disease therapy
    • Receipt of Crohn's disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
    • Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors (e.g., risankizumab)
    • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
    • Having an ostomy or ileoanal pouch