Clinical trial NCT05394792: 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
Official title: CANadian Effectiveness of UPadacitinib in Adult Moderate-to-severe aTopIc derMatitis Patients Who Are Inadequate Responders to Dupilumab or diScontinuing Dupilumab Due to safEty/Tolerability Reasons: The CAN UpTIMISE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis (AD)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderate-to-severe Atopic Dermatitis who are inadequate responders to dupilumab or are discontinuing from dupilumab due to safety/tolerability reasons.

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
timeFrame: Month 4
Secondary outcomes:
measure: Percentage of Participants Achieving vlGA-AD of 0 or 1
timeFrame: Up to 2 Months
measure: Percentage of Participants Achieving vlGA-AD of ≥ 2 at baseline reaching a vIGA-AD score of 0 or 1
timeFrame: Up to 4 Months
measure: Percentage of Participants with a vIGA score 0 or 1 at Baseline Maintaining a vIGA-AD score 0 or 1
timeFrame: From Baseline to Month 4
measure: Percentage of Participants with an Eczema Area and Severity Index (EASI) score corresponding to, at least, mild disease (≥1.1) at baseline achieving an absolute EASI score corresponding to clear or almost clear disease (<1.1)
timeFrame: Up to 4 Months
measure: Percentage of Participants with an EASI score corresponding to, at least, moderate disease (≥7.1) at baseline achieving an absolute EASI score corresponding to mild disease (<7.1)
timeFrame: Up to 4 Months
measure: Absolute mean EASI score
timeFrame: Up to 4 Months
measure: Percent change in EASI score from baseline
timeFrame: Up to 4 Months
measure: Mean change in EASI score from baseline
timeFrame: Up to 4 Months
measure: Percent change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])
timeFrame: Up to 4 Months
measure: Mean change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])
timeFrame: Up to 4 Months
measure: Percent change in Worst pruritus numerical rating scale (WP-NRS) score from baseline
timeFrame: Up to 4 Months
measure: Mean change in WP-NRS score from baseline
timeFrame: Up to 4 Months
measure: Percentage of Participants with WP-NRS >2 at baseline achieving a WP-NRS score of 0 or 1
timeFrame: Up to 4 Months
measure: Percentage of Participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1
timeFrame: Up to 4 Months
measure: Percentage of Participants with a baseline DLQI score ≥ 2 (at least small effect on participant's quality of life) achieving a DLQI score of 0 or 1
timeFrame: Up to 4 Months
measure: Absolute mean DLQI scores
timeFrame: Up to 4 Months
measure: Percent change in DLQI score from Baseline
timeFrame: Up to 4 Months
measure: Mean change in DLQI score from Baseline
timeFrame: Up to 4 Months
measure: Absolute mean Patient Oriented Eczema Measurement (POEM) score
timeFrame: Up to 4 Months
measure: Percent change in POEM score from baseline
timeFrame: Up to 4 Months
measure: Mean change in POEM score from baseline
timeFrame: Up to 4 Months
measure: Percentage of Participants with a baseline POEM score ≥ 4 achieving an improvement (reduction) in POEM ≥ 4 at Month 4
timeFrame: Up to 4 Months
measure: Percentage of Participants achieving a POEM score of ≤2 among participants with POEM >2 at baseline
timeFrame: Up to 4 Months
measure: Percent change in Body surface area (BSA) score from baseline
timeFrame: Up to 4 Months
measure: Mean change in BSA score from baseline
timeFrame: Up to 4 Months
measure: Percentage of Participants who are "Very much improved" or "Much improved" on the Patient Global Impression of Change (PGIC)
timeFrame: Up to 4 Months
measure: Percentage of Participants who report symptoms to be "Minimal" or "Absent" on the Patient Global Impression of Severity (PGIS)
timeFrame: Up to 4 Months
measure: Percentage of Participants who report symptoms to be "Very satisfied" or "Extremely satisfied" on the Patient Global Impression of Treatment (PGIT)
timeFrame: Up to 4 Months
measure: Number of participants who used concomitant AD medications along with upadacitinib since last visit
timeFrame: Up to 4 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Dermatology Research Institute - Blackfoot Trail /ID# 246344
state: Alberta
city: Calgary
country: Canada
facility: Laser Rejuvenation Clinics Inc. /ID# 255303
state: Alberta
city: Calgary
country: Canada
facility: Rejuvenation Dermatology Clinic Calgary North /ID# 255623
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology - Edmonton Downtown /ID# 246298
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical /ID# 254940
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvaderm /ID# 255850
state: Alberta
city: Edmonton
country: Canada
facility: Alpha Clinic Research Inc. /ID# 248015
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 246841
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health /ID# 248136
state: Nova Scotia
city: London
country: Canada
facility: Fiona Lovegrove Medicine Professional Corporation /ID# 255784
state: Ontario
city: Markham
country: Canada
facility: Lynde Institute for Dermatology /ID# 246341
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada Inc. /ID# 251916
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology /ID# 246291
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre /ID# 246921
state: Ontario
city: Toronto
country: Canada
facility: Canadian Dermatology Centre /ID# 246334
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology /ID# 254914
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm, Toronto, CA /ID# 250941
state: Ontario
city: Toronto
country: Canada
facility: Evidence based medical educator Inc. /ID# 246687
state: Ontario
city: Drummondville
country: Canada
facility: Dr. Isabelle Delorme Inc. /ID# 246296
state: Quebec
city: Laval
country: Canada
facility: Clinique D /ID# 247330
state: Quebec
city: Laval
country: Canada
facility: Roula Rassi MD Inc /ID# 252563
state: Quebec
city: Quebec City
country: Canada
facility: Centre de Recherche St-Louis /ID# 252223
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche Québec Inc. /ID# 247696
state: Quebec
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 246457
state: Quebec
city: Verdun
country: Canada
facility: Sima Recherche inc. /ID# 248338
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: