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View trial details
Overview
Official protocol title:
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK
EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF
RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
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.
RITLECITINIB (PF-06651600)
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'.
B7981080
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
277928
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 23, 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 -
NCT06072183
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
Centre de Recherche Dermatologique du Quebec metropolitain
Alberta
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
British Columbia
The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
Manitoba
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Ontario
Dermatology on Bloor - Research Toronto
Toronto, Ontario, M4W 2N4
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3
North York Research Inc
Toronto, Ontario, M2N 3A6
SimcoDerm Medical and Surgical Dermatology Center
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B 1L1
Quebec
Centre de Recherche Saint-Louis
Montreal, Quebec, H1Y 3L1
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, J1G 1X9
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
Saskatchewan
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
