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

NCT05394792 | Completed

• 1 other identifier: P23-106
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 25

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis (AD); Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1

  vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

  Month 4

Secondary Outcomes (29)

• Percentage of Participants Achieving vlGA-AD of 0 or 1

  Up to 2 Months

• Percentage of Participants Achieving vlGA-AD of ≥ 2 at baseline reaching a vIGA-AD score of 0 or 1

  Up to 4 Months

• Percentage of Participants with a vIGA score 0 or 1 at Baseline Maintaining a vIGA-AD score 0 or 1

  From Baseline to Month 4

• 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)

  Up to 4 Months

• 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)

  Up to 4 Months

Study Arms (1)

Participants Receiving Upadacitinib

Participants receiving upadacitinib for moderate to severe atopic dermatitis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (25)

Dermatology Research Institute - Blackfoot Trail /ID# 246344

Calgary, Alberta, T2J 7E1, Canada

Location

Laser Rejuvenation Clinics Inc. /ID# 255303

Calgary, Alberta, T2W 4X9, Canada

Location

Rejuvenation Dermatology Clinic Calgary North /ID# 255623

Calgary, Alberta, T3K 6B8, Canada

Location

Rejuvenation Dermatology - Edmonton Downtown /ID# 246298

Edmonton, Alberta, T5J 3S9, Canada

Location

Stratica Medical /ID# 254940

Edmonton, Alberta, T5K 2V4, Canada

Location

Rejuvaderm /ID# 255850

Edmonton, Alberta, T5N 1L5, Canada

Location

Alpha Clinic Research Inc. /ID# 248015

Edmonton, Alberta, T6X 0N9, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 246841

Surrey, British Columbia, V3R 6A7, Canada

Location

Nova Scotia Health /ID# 248136

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Fiona Lovegrove Medicine Professional Corporation /ID# 255784

London, Ontario, N6A 5R9, Canada

Location

Lynde Institute for Dermatology /ID# 246341

Markham, Ontario, L3P 1X2, Canada

Location

Allergy Research Canada Inc. /ID# 251916

Niagara Falls, Ontario, L2H 1H5, Canada

Location

SKiN Centre for Dermatology /ID# 246291

Peterborough, Ontario, K9J 5K2, Canada

Location

York Dermatology Clinic and Research Centre /ID# 246921

Richmond Hill, Ontario, L4B 1L1, Canada

Location

Canadian Dermatology Centre /ID# 246334

Toronto, Ontario, M3B 0A7, Canada

Location

FACET Dermatology /ID# 254914

Toronto, Ontario, M4C 1L1, Canada

Location

AvantDerm, Toronto, CA /ID# 250941

Toronto, Ontario, M5A 3R6, Canada

Location

Evidence based medical educator Inc. /ID# 246687

Toronto, Ontario, M5G 1E2, Canada

Location

Dr. Isabelle Delorme Inc. /ID# 246296

Drummondville, Quebec, J2B 5L4, Canada

Location

Clinique D /ID# 247330

Laval, Quebec, H7N 6L2, Canada

Location

Roula Rassi MD Inc /ID# 252563

Laval, Quebec, H7P 4K7, Canada

Location

Diex Recherche Québec Inc. /ID# 247696

Québec, Quebec, G1V 4T3, Canada

Location

Centre de Recherche St-Louis /ID# 252223

Québec, Quebec, G1W 4R4, Canada

Location

Dre Angelique Gagne-Henley M.D. inc. /ID# 246457

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Sima Recherche inc. /ID# 248338

Verdun, Quebec, H4G 3E7, Canada

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2022
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CA (25)