CAN UpTIMISE

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

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.

Observational study

Status:
Recruiting
Conditions:
Atopic Dermatitis
Enrollment:
100 patients
Protocol ID:
P23-106
Observational model:
Cohort
Time perspective:
Prospective

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located

Surrey - V3R 6A7
Halifax - B3H 1V7
Markham - L3P 1X2
Peterborough - K9J 5K2
Richmond Hill - L4C 9M7
Drummondville - J2B 5L4
Laval - H7N 6L2
Saint-Jerome - J7Z 7E2
Verdun - H4G 3E7

More information about this study

clinicaltrials.gov