A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Last updated:
Last updated
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2026-08-01
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A PHASE 3B/4 RANDOMIZED, OPEN-LABEL, EFFICACY ASSESSOR BLINDED STUDY, COMPARING THE SAFETY AND ASSESSOR BLINDED EFFICACY OF UPADACITINIB TO DUPILUMAB IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS (LEVEL-UP)
Intervention/treatment:
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.
UPADACITINIB (ABT-494)
Medical condition:
Medical condition
The disease or condition that's being studied in the clinical trial.
ATOPIC DERMATITIS
Protocol code:
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'.
M23-696
Control number:
Control number
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
267089
Status:
Trial 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:
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 17, 2022
Date Completed:
Date completed
The date of the last participant’s last visit in the global study. The completion date may be actual or estimated, depending what was provided to the registry. Estimated completion dates may be in the past or future.
Trial phase:
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
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
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
Age
12 Years to 64 Years
Accepts healthy volunteers:
No
Contacts and locations
Contact
Contact
Information for an individual or organisation that can respond to questions about this clinical trial. This information comes from the international registry.
The sponsor conducts the clinical trial and is responsible for every aspect. For example this could be a company, a university or an individual researcher.
ABBVIE CORPORATION
Locations
Alberta
Alberta DermaSurgery Centre /ID# 250217
Edmonton, Alberta, T6G 1C3
Beacon Dermatology Inc /ID# 250336
Calgary, Alberta, T3A 2N1
Dermatology Research Institute - Blackfoot Trail /ID# 251642
Calgary, Alberta, T2J 7E1
British Columbia
Dr. Chih-ho Hong Medical Inc. /ID# 251643
Surrey, British Columbia, V3R 6A7
Enverus Medical Research /ID# 251645
Surrey, British Columbia, V3V 0C6
Manitoba
Wiseman Dermatology Research /ID# 250219
Winnipeg, Manitoba, R3M 3Z4
New Brunswick
Brunswick Dermatology Center /ID# 250220
Fredericton, New Brunswick, E3B 1G9
Ontario
DermEdge Research Inc. /ID# 250216
Mississauga, Ontario, L4Y 4C5
DermEffects /ID# 250223
London, Ontario, N6H 5L5
LEADER Research /ID# 251647
Hamilton, Ontario, L8L 3C3
Lynde Institute for Dermatology /ID# 251854
Markham, Ontario, L3P 1X2
Private Practice - Dr. Kim Papp Clinical Research /ID# 251644
Waterloo, Ontario, N2J 1C4
Research Toronto /ID# 250222
Toronto, Ontario, M4W 2N4
SKiN Centre for Dermatology /ID# 251853
Peterborough, Ontario, K9J 5K2
Toronto Dermatology Centre /ID# 252098
Toronto, Ontario, M3H 5Y8
Quebec
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427
