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View trial details
Overview
Official protocol title:
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BARZOLVOLIMAB IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA WHO REMAIN SYMPTOMATIC DESPITE H1 ANTIHISTAMINE TREATMENT (EMBARQ - CSU2)
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.
CDX-0159
Medical condition:
The disease or condition that's being studied in the clinical trial.
CHRONIC SPONTANEOUS URTICARIA
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'.
CDX0159-13
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
289835
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.
Active, not 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.
October 04, 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 -
NCT06455202
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
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, T5J 3S9
RECRUITING
Rejuvenation Dermatology Edmonton South
Edmonton, Alberta, T6W 0J5
RECRUITING
Vida Clinical Research
Edmonton, Alberta, T6H 4J8
RECRUITING
Ontario
Centre de Recherche Saint-Louis (Québec)
Québec, Ontario, G1W4R4
RECRUITING
DermEffects
London, Ontario, N6H 5L5
RECRUITING
Joel Liem Medicine Professional Corporation
Windsor, Ontario, N8X 2G1
RECRUITING
Kingston Health Science Center
Kingston, Ontario, K7L 2V7
RECRUITING
LEADER research
Hamilton, Ontario, L8L 3C3
RECRUITING
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
RECRUITING
North York Research Inc.
Toronto, Ontario, M2N 3A6
RECRUITING
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H1E4
RECRUITING
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B 1L1
RECRUITING
Saskatchewan
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T0G3
RECRUITING
