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

Study Identifier
P23-106
CT.gov Identifier
NCT05394792
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Dermatology Research Institute - Blackfoot Trail /ID# 246344
    Calgary, Alberta, Canada, T2J 7E1
    Status
    Not applicable
    Location
    Laser Rejuvenation Clinics Inc. /ID# 255303
    Calgary, Alberta, Canada, T2W 4X9
    Status
    Not applicable
    Location
    Rejuvenation Dermatology Clinic Calgary North /ID# 255623
    Calgary, Alberta, Canada, T3K 6B8
    Status
    Not applicable
    Location
    Rejuvenation Dermatology - Edmonton Downtown /ID# 246298
    Edmonton, Alberta, Canada, T5J 3S9
    Status
    Not applicable
    Location
    Stratica Medical /ID# 254940
    Edmonton, Alberta, Canada, T5K 2V4
    Status
    Not applicable
    Location
    Rejuvaderm /ID# 255850
    Edmonton, Alberta, Canada, T5N 1L5
    Status
    Not applicable
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