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View trial details
Overview
Official protocol title:
¿RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE 3 STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SAR440340/REGN3500/ITEPEKIMAB (ANTI-IL-33 MAB) IN PATIENTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)¿
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.
SAR440340/REGN3500
Medical condition:
The disease or condition that's being studied in the clinical trial.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
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'.
EFC16819
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
245891
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:
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.
December 02, 2020
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 -
NCT04751487
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
Investigational Site Number : 1240006
Sherwood Park, Alberta, T8H 0N2
British Columbia
Investigational Site Number : 1240014
Kelowna, British Columbia, V1Y 4N7
Investigational Site Number : 1240016
Penticton, British Columbia, V2A 5L5
New Brunswick
Investigational Site Number : 1240012
Moncton, New Brunswick, E1C2Z3
Ontario
Investigational Site Number : 1240003
Investigational Site Number : 1240009
Toronto, Ontario, M5T 3A9
Investigational Site Number : 1240018
Windsor, Ontario, N8X 5A6
Investigational Site Number : 1240020
Burlington, Ontario, L7N 3V2
Investigational Site Number : 1240021
Investigational Site Number : 1240022
Windsor, Ontario, N8X 1T3
Investigational Site Number : 1240023
Quebec
Investigational Site Number : 1240001
Trois-Rivières, Quebec, G8T 7A1
Investigational Site Number : 1240002
Victoriaville, Quebec, G6P 3Z8
Investigational Site Number : 1240004
Sherbrooke, Quebec, J1H 5N4
Investigational Site Number : 1240005
St-charles Borrommee, Quebec, J6E 2B4
Investigational Site Number : 1240019
Terrebonne, Quebec, J6V 2H2
