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View trial details
Overview
Official protocol title:
A PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO- AND ACTIVE COMPARATOR- CONTROLLED STUDY WITH A RANDOMIZED WITHDRAWAL AND RETREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-279 IN SUBJECTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS
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.
ZASOCITINIB (TAK-279, NDI-034858)/ APREMILAST
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'.
TAK-279-3002
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
281473
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 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 -
NCT06108544
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
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, T6G 1C2 Canada
CaRe Clinic-Red Deer
Red Deer, Alberta, T4N 7C3
Dermatology Research Institute, Inc. - Probity - PPDS
Calgary, Alberta, T3A 2N1
VIDA Dermatology - Probity - PPDS
Edmonton, Alberta, T6H 4J8
Manitoba
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba, R3E 0V9
New Brunswick
Brunswick Dermatology Centre - Probity - PPDS
Fredericton, New Brunswick, E3B 1G9
Ontario
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario, N2J 1C4
Canadian Dermatology Centre - Probity - PPDS
Toronto, Ontario, M3B 0A7
Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
Richmond Hill, Ontario, L4B 1M5
Dermatrials Research
Hamilton, Ontario, L8N 1Y2
DermEdge Research - Probity - PPDS
Mississauga, Ontario, L4Y 4C5
DermEffects - Probity - PPDS
Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
Richmond Hill, Ontario, L4C 9M7
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
Hamilton, Ontario, L8L 3C3
Lynderm Research Inc - Probity - PPDS
Markham, Ontario, L3P 1X3
Oshawa Clinic-117 King St
SKiN Centre for Dermatology - Peterborough - Probity - PPDS
Peterborough, Ontario, K9J 1Z2
The Centre for Clinical Trials Inc. - Probity - PPDS
Oakville, Ontario, L6J 7W5
Toronto Research Centre - Probity - PPDS
Toronto, Ontario, M3H 5Y8
XLR8 Medical Research - Probity - PPDS
Windsor, Ontario, N8X 3V6
Quebec
Siena Medical Research
Westmount, Quebec, H3Z 2S6
Saskatchewan
Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS
Saskatoon, Saskatchewan, S7K 0H6
