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 (CAN UpTIMISE)

AbbVie

Status: Completed

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05394792

P23-106

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

111 participants in 1 patient group

Participants Receiving Upadacitinib

Description:

Participants receiving upadacitinib for moderate to severe atopic dermatitis.