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ClinicalTrial.gov Identifier : NCT03398148

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy 

    Status Recruiting
    Related Conditions
    Ulcerative Colitis

Enrollment Details

720 Worldwide Enrollment Goal

Phases: 

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

This is a type II and III phase trial.

Protocol ID
M16-067

Brief summary

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The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

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

Canada: 14

0
Calgary, AB
1
Edmonton, AB
2
Edmonton, AB
3
Edmonton, AB
4
New Westminster, BC
5
Victoria, BC
6
Halifax, NS
7
Halifax, NS
8
London, ON
9
North Bay, ON
10
Vaughan, ON
11
Greenfield Park, QC
12
Montreal, QC
13
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.
    ?

    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

    • Male or female aged >=18 to <= 80 years 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
    • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
    • Active UC as assessed by adapted Mayo Score
    • Demonstrated intolerance or inadequate response to one or more biologic therapies
    • Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.
    • Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
    • Subject receiving prohibited medications and treatment.
    • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
    • Subject with currently known complications of UC (e.g., megacolon).

More on this trial

Clinical Trials.gov