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

Last updated: August 14, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Allergy

Rash

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT05394792
P23-106
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 totreat with upadacitinib must have been made with the participant, prior to andindependently of enrolment in the study

  • Previous treatment with dupilumab for AD, as the most recent systemic therapy, andwho is either or:

  • i. sub-optimally controlled as per investigator judgement, after at least 16weeks of dupilumab treatment, with or without additional AD therapies, at timeof baseline visit.

  • ii. discontinuing dupilumab due to safety/tolerability reason(s) as perinvestigator judgement at the baseline visit

  • Availability of medication history during the past 4 weeks prior to baseline visit

Exclusion

Exclusion Criteria:

  • Previous treatment with any systemic JAKi including upadacitinib, or anyinvestigational drug of chemical or biologic nature within 4 weeks or fivehalf-lives of the drug (whichever is longer) prior to and at the time of thebaseline visit

  • Currently enrolled in an interventional clinical study, or within the last 30 daysor five-half lives of being administered an investigational drug, whichever islonger, prior to baseline visit. Participation in other observational studies orregistries is acceptable.

Study Design

Total Participants: 111
Study Start date:
June 01, 2022
Estimated Completion Date:
August 15, 2024

Connect with a study center

  • Dermatology Research Institute - Blackfoot Trail /ID# 246344

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Dermatology Research Institute Inc. /ID# 246344

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Laser Rejuvenation Clinics Inc. /ID# 255303

    Calgary, Alberta T2W 4X9
    Canada

    Site Not Available

  • Rejuvenation Dermatology Clinic Calgary North /ID# 255623

    Calgary, Alberta T3K 6B8
    Canada

    Site Not Available

  • Alpha Clinic Research Inc. /ID# 248015

    Edmonton, Alberta T6X 0N9
    Canada

    Site Not Available

  • Laser Rejuvenation Clinics Edmonton D.T. Inc. /ID# 246298

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Rejuvaderm /ID# 255850

    Edmonton, Alberta T5N 1L5
    Canada

    Site Not Available

  • Rejuvenation Dermatology - Edmonton Downtown /ID# 246298

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Stratica Dermatology /ID# 254940

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Stratica Medical /ID# 254940

    Edmonton, Alberta T5K 2V4
    Canada

    Site Not Available

  • SkinCareWest /ID# 247235

    Nanaimo, British Columbia V9V 1A3
    Canada

    Site Not Available

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

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Wiseman Dermatology Research /ID# 246340

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Nova Scotia Health /ID# 248136

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Fiona Lovegrove Medicine Professional Corporation /ID# 255784

    London, Ontario N6A 5R9
    Canada

    Site Not Available

  • Lynde Institute for Dermatology /ID# 246341

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Lynderm Research Inc. /ID# 246341

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Allergy Research Canada Inc. /ID# 251916

    Niagara Falls, Ontario L2H 1H5
    Canada

    Site Not Available

  • SKIN Centre for Dermatology /ID# 246291

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • SKiN Centre for Dermatology /ID# 246291

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • York Dermatology Clinic and Research Centre /ID# 246921

    Richmond Hill, Ontario L4B 1L1
    Canada

    Site Not Available

  • AvantDerm, Toronto, CA /ID# 250941

    Toronto, Ontario M5A 3R6
    Canada

    Site Not Available

  • Canadian Dermatology Centre /ID# 246334

    Toronto, Ontario M3B 0A7
    Canada

    Site Not Available

  • Evidence based medical educator Inc. /ID# 246687

    Toronto, Ontario M5G 1E2
    Canada

    Site Not Available

  • FACET Dermatology /ID# 254914

    Toronto, Ontario M4C 1L1
    Canada

    Site Not Available

  • Dr. Isabelle Delorme Inc. /ID# 246296

    Drummondville, Quebec J2B 5L4
    Canada

    Site Not Available

  • Clinique D /ID# 247330

    Laval, Quebec H7N 6L2
    Canada

    Site Not Available

  • Roula Rassi MD Inc /ID# 252563

    Laval, Quebec H7P 4K7
    Canada

    Site Not Available

  • Innovaderm Research Inc. /ID# 248338

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Centre de Recherche St-Louis /ID# 252223

    Quebec City, Quebec G1W 4R4
    Canada

    Site Not Available

  • Diex Recherche Québec Inc. /ID# 247696

    Québec, Quebec G1V 4T3
    Canada

    Site Not Available

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

    Saint-Jerome, Quebec J7Z 7E2
    Canada

    Site Not Available

  • Sima Recherche inc. /ID# 248338

    Verdun, Quebec H4G 3E7
    Canada

    Site Not Available

  • Sudbury Skin Clinique /ID# 246844

    Sudbury, P3C 1X8
    Canada

    Site Not Available

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