A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Last updated:
Last updated
The date of the most recent update for each trial record in the Canadian Clinical Trial Search Portal.
2026-07-11
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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
Intervention/treatment:
Intervention/treatment
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
RISANKIZUMAB (ABBV-066)
Medical condition:
Medical condition
The disease or condition that's being studied in the clinical trial.
ULCERATIVE COLITIS
Protocol code:
Protocol Code
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
M16-067
Control number:
Control number
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
215884
Status:
Trial Status
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site. • Recruiting - Participants are currently being recruited. • Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled. • On hold - The clinical trial has been temporarily stopped, but it may start again. • Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again. • Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor. • No match, ongoing - Please contact sponsor for status information. • Other - Please contact sponsor for status information.
Closed
Approved:
Approved
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
May 29, 2018
Date Completed:
Date completed
The date of the last participant’s last visit in the global study. The completion date may be actual or estimated, depending what was provided to the registry. Estimated completion dates may be in the past or future.
Trial phase:
Trial phase
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Age
16 Years to 80 Years
Accepts healthy volunteers:
No
Contacts and locations
Contact
Contact
Information for an individual or organisation that can respond to questions about this clinical trial. This information comes from the international registry.
The sponsor conducts the clinical trial and is responsible for every aspect. For example this could be a company, a university or an individual researcher.
ABBVIE CORPORATION
Locations
Alberta
Allen Whey Khye Lim Professional Corporation /ID# 169767
Edmonton, Alberta, T5R 1W2
Covenant Health /ID# 169114
Edmonton, Alberta, T6K 4B2
University of Calgary /ID# 169111
Calgary, Alberta, T2N 4Z6
British Columbia
Fraser Clinical Trials Inc /ID# 169102
New Westminster, British Columbia, V3L 3W4
Percuro Clinical Research, Ltd /ID# 169109
Victoria, British Columbia, V8V 3M9
Ontario
London Health Sciences Center- University Hospital /ID# 169103
London, Ontario, N6A 5W9
Scott Shulman Medicine Professional Corporation /ID# 169113
North Bay, Ontario, P1B 2H3
Toronto Digestive Disease Asso /ID# 169106
Vaughan, Ontario, L4L 4Y7
Quebec
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108
Montreal, Quebec, H1T 2M4
Hotel Dieu de Levis /ID# 214378
Lévis, Quebec, G6V 3Z1
Royal Victoria Hospital / McGill University Health Centre /ID# 169104
