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

NCT ID: NCT05394792

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-08-15

Brief Summary

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.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants Receiving Upadacitinib

Participants receiving upadacitinib for moderate to severe atopic dermatitis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Dermatology Research Institute - Blackfoot Trail /ID# 246344

Calgary, Alberta, Canada

Laser Rejuvenation Clinics Inc. /ID# 255303

Calgary, Alberta, Canada

Rejuvenation Dermatology Clinic Calgary North /ID# 255623

Calgary, Alberta, Canada

Rejuvenation Dermatology - Edmonton Downtown /ID# 246298

Edmonton, Alberta, Canada

Stratica Medical /ID# 254940

Edmonton, Alberta, Canada

Rejuvaderm /ID# 255850

Edmonton, Alberta, Canada

Alpha Clinic Research Inc. /ID# 248015

Edmonton, Alberta, Canada

Dr. Chih-ho Hong Medical Inc. /ID# 246841

Surrey, British Columbia, Canada

Nova Scotia Health /ID# 248136

Halifax, Nova Scotia, Canada

Fiona Lovegrove Medicine Professional Corporation /ID# 255784

London, Ontario, Canada

Lynde Institute for Dermatology /ID# 246341

Markham, Ontario, Canada

Allergy Research Canada Inc. /ID# 251916

Niagara Falls, Ontario, Canada

SKiN Centre for Dermatology /ID# 246291

Peterborough, Ontario, Canada

York Dermatology Clinic and Research Centre /ID# 246921

Richmond Hill, Ontario, Canada

Canadian Dermatology Centre /ID# 246334

Toronto, Ontario, Canada

FACET Dermatology /ID# 254914

Toronto, Ontario, Canada

AvantDerm, Toronto, CA /ID# 250941

Toronto, Ontario, Canada

Evidence based medical educator Inc. /ID# 246687

Toronto, Ontario, Canada

Dr. Isabelle Delorme Inc. /ID# 246296

Drummondville, Quebec, Canada

Clinique D /ID# 247330

Laval, Quebec, Canada

Roula Rassi MD Inc /ID# 252563

Laval, Quebec, Canada

Diex Recherche Québec Inc. /ID# 247696

Québec, Quebec, Canada

Centre de Recherche St-Louis /ID# 252223

Québec, Quebec, Canada

Dre Angelique Gagne-Henley M.D. inc. /ID# 246457

Saint-Jérôme, Quebec, Canada

Sima Recherche inc. /ID# 248338

Verdun, Quebec, Canada

Countries

Canada

Related Links

https://www.abbvieclinicaltrials.com/study/?id=P23-106#additional-resources-section

Clinical Study Report Synopsis

Other Identifiers

P23-106

Identifier Type: -

Identifier Source: org_study_id