Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2024
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT05394792
Start Date
June 1 2022
End Date
August 15 2024
Last Update
August 19 2025
Active Locations (25)
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1
Dermatology Research Institute - Blackfoot Trail /ID# 246344
Calgary, Alberta, Canada, T2J 7E1
2
Laser Rejuvenation Clinics Inc. /ID# 255303
Calgary, Alberta, Canada, T2W 4X9
3
Rejuvenation Dermatology Clinic Calgary North /ID# 255623
Calgary, Alberta, Canada, T3K 6B8
4
Rejuvenation Dermatology - Edmonton Downtown /ID# 246298
Edmonton, Alberta, Canada, T5J 3S9