NCT05394792Completed
An Observational Study of Upadacitinib to Assess Change in Disease Activity in Canadian Adult Participants With Moderate-to-Severe Atopic Dermatitis Who Are Inadequate Responders To or Discontinuing Dupilumab
CANadian Effectiveness of UPadacitinib in Adult Moderate-to-severe aTopIc derMatitis Patients Who Are Inadequate Responders to Dupilumab or diScontinuing Dupilumab Due to safEty/Tolerability Reasons: The CAN UpTIMISE Study
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on adult participants with moderate-to-severe AD who are inadequate responders to dupilumab or who are discontinuing from dupilumab due to safety/tolerability reasons. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice. In Canada, upadacitinib is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable. CAN UpTIMISE will enroll approximately 100 adult participants, 18 years of age and above, with moderate-to-severe AD who are inadequate responders to dupilumab or are discontinuing from dupilumab from up to 25 sites in Canada. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 4 Months. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, using questionnaires, and reporting potential side-effects.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 111 (actual)
- First submitted
- 25 May 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- AbbVie
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05394792
What you commit to
- Study type: Observational
- Participants enrolled: 111
- From 1 Jun 2022 to the primary completion date, 15 Aug 2024
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with any systemic JAKi including upadacitinib, or any investigational drug of chemical or biologic nature within 4 weeks or five half-lives of the drug (whichever is longer) prior to and at the time of the baseline visit
- Currently enrolled in an interventional clinical study, or within the last 30 days or five-half lives of being administered an investigational drug, whichever is longer, prior to baseline visit. Participation in other observational studies or registries is acceptable.
Who the study is looking for
- Able to give written informed consent before starting any study-related assessments
- Diagnosis of moderate or severe AD, as per investigator's judgement
- Initiating upadacitinib treatment, as per the local label, and where decision to treat with upadacitinib must have been made with the participant, prior to and independently of enrolment in the study
- Previous treatment with dupilumab for AD, as the most recent systemic therapy, and who is either or:
- i. sub-optimally controlled as per investigator judgement, after at least 16 weeks of dupilumab treatment, with or without additional AD therapies, at time of baseline visit.
- ii. discontinuing dupilumab due to safety/tolerability reason(s) as per investigator judgement at the baseline visit
- Availability of medication history during the past 4 weeks prior to baseline visit
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rejuvenation Dermatology Clinic Calgary North /ID# 255623 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Dermatology Research Institute - Blackfoot Trail /ID# 246344 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Laser Rejuvenation Clinics Inc. /ID# 255303 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Dr. Isabelle Delorme Inc. /ID# 246296 Coordinator of this site? Confirm its status | Drummondville | Canada | Unknown status |
| Stratica Medical /ID# 254940 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Rejuvenation Dermatology - Edmonton Downtown /ID# 246298 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Rejuvaderm /ID# 255850 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Alpha Clinic Research Inc. /ID# 248015 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Nova Scotia Health /ID# 248136 Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Roula Rassi MD Inc /ID# 252563 Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Clinique D /ID# 247330 Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Fiona Lovegrove Medicine Professional Corporation /ID# 255784 Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Lynde Institute for Dermatology /ID# 246341 Coordinator of this site? Confirm its status | Markham | Canada | Unknown status |
| Allergy Research Canada Inc. /ID# 251916 Coordinator of this site? Confirm its status | Niagara Falls | Canada | Unknown status |
| SKiN Centre for Dermatology /ID# 246291 Coordinator of this site? Confirm its status | Peterborough | Canada | Unknown status |
| Diex Recherche Québec Inc. /ID# 247696 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Centre de Recherche St-Louis /ID# 252223 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| York Dermatology Clinic and Research Centre /ID# 246921 Coordinator of this site? Confirm its status | Richmond Hill | Canada | Unknown status |
| Dre Angelique Gagne-Henley M.D. inc. /ID# 246457 Coordinator of this site? Confirm its status | Saint-Jérôme | Canada | Unknown status |
| Dr. Chih-ho Hong Medical Inc. /ID# 246841 Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Evidence based medical educator Inc. /ID# 246687 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| FACET Dermatology /ID# 254914 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| AvantDerm, Toronto, CA /ID# 250941 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Canadian Dermatology Centre /ID# 246334 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sima Recherche inc. /ID# 248338 Coordinator of this site? Confirm its status | Verdun | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.