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View trial details
Overview
Official protocol title:
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROGRAM TO
EVALUATE THE EFFICACY AND SAFETY OF TULISOKIBART IN PARTICIPANTS WITH
MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE
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.
MK-7240
Medical condition:
The disease or condition that's being studied in the clinical trial.
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'.
MK-7240-008
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
288139
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.
Recruiting
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.
July 26, 2024
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
Phase 3
For more information:
ClinicalTrials.gov -
NCT06430801
This is an external link. The information is not authorized by the Government of Canada.
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
Accepts healthy volunteers:
No
Locations
Alberta
Gastroenterology and internal medicine research institute ( Site 0009)
Edmonton, Alberta, T5R 1W2
Recruiting
Heritage Medical Research Clinic ( Site 0004)
Calgary, Alberta, T2N 4Z6
Recruiting
Prairie Institute of Liver and Luminal Advanced Research ( Site 0015)
Lethbridge, Alberta, T1J 4G9
Recruiting
British Columbia
Fraser Clinical Trials Inc ( Site 0001)
New Westminster, British Columbia, V3L 3W4
Recruiting
G.I.R.I. GI Research Institute Foundation ( Site 0018)
Vancouver, British Columbia, V6Z 2K5
Recruiting
Nova Scotia
Private Practice - Dr. Bruce Musgrave ( Site 0014)
Kentville, Nova Scotia, B4N 0A3
Recruiting
Ontario
ABP Research Services Corp. ( Site 0019)
Oakville, Ontario, L6L 5L7
Recruiting
Barrie GI Associates ( Site 0016)
Barrie, Ontario, L4M 7G1
Recruiting
London Health Sciences Centre ( Site 0007)
London, Ontario, N6A 5W9
Recruiting
TDDA Inc. ( Site 0006)
Vaughan, Ontario, L4L 4Y7
Active, not recruiting
Toronto Immune & Digestive Health Institute ( Site 0005)
Toronto, Ontario, M6A 3B4
Recruiting
University Hospital - London Health Sciences Centre ( Site 0002)
London, Ontario, N6A 5A5
Recruiting
West GTA Research Inc. ( Site 0020)
Mississauga, Ontario, L5M 2S4
Recruiting
Quebec
Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)
Lévis, Quebec, G6V 3Z1
Recruiting
Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)
Montreal, Quebec, H2X 0C1
Recruiting
Diex Recherche Quebec ( Site 0008)
Québec, Quebec, G1V 4T3
COMPLETED
Montreal General Hospital ( Site 0003)
Montreal, Quebec, H3G 1A4
Recruiting