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View trial details
Overview
Official protocol title:
A GLOBAL, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP, PHASE 3B STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF REMIBRUTINIB 25 MG B.I.D. IN COMPARISON TO PLACEBO WITH OMALIZUMAB 300 MG EVERY 4 WEEKS AS ACTIVE CONTROL OVER 52 WEEKS IN ADULT PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA INADEQUATELY CONTROLLED BY SECOND-GENERATION H1-ANTIHISTAMINES, AND AN OPEN-LABEL 52-WEEK OPTIONAL EXTENSION TO ASSESS LONG-TERM EFFICACY, SAFETY AND TOLERABILITY OF REMIBRUTINIB 25 MG B.I.D.
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.
REMIBRUTINIB (LOU064)
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'.
CLOU064A2304
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
272168
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.
August 18, 2023
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 -
NCT06042478
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
Novartis Investigative Site
Edmonton, Alberta, T6G 1C3
Ontario
Novartis Investigative Site
Hamilton, Ontario, L8L 3C3
Novartis Investigative Site
Hamilton, Ontario, L8S 1G5
Novartis Investigative Site
Novartis Investigative Site
Niagara Falls, Ontario, L2H 1H5
Quebec
Novartis Investigative Site
Novartis Investigative Site
