Atopic DermatitisCAN UpTIMISENCT05394792
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
An observational study of Atopic Dermatitis, run by AbbVie at 25 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 111 participants
- Where
- 25 sitesCanada
- Study dates
- 1 Jun 2022to 15 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
25 sites in 1 country.
25 sites in 1 country
Canada25 sites
Dermatology Research Institute - Blackfoot Trail /ID# 246344
Calgary, Alberta, T2J 7E1
Laser Rejuvenation Clinics Inc. /ID# 255303
Calgary, Alberta, T2W 4X9
Rejuvenation Dermatology Clinic Calgary North /ID# 255623
Calgary, Alberta, T3K 6B8
Dr. Isabelle Delorme Inc. /ID# 246296
Drummondville, Quebec, J2B 5L4
Rejuvenation Dermatology - Edmonton Downtown /ID# 246298
Edmonton, Alberta, T5J 3S9
Stratica Medical /ID# 254940
Edmonton, Alberta, T5K 2V4
Rejuvaderm /ID# 255850
Edmonton, Alberta, T5N 1L5
Alpha Clinic Research Inc. /ID# 248015
Edmonton, Alberta, T6X 0N9
Nova Scotia Health /ID# 248136
Halifax, Nova Scotia, B3H 1V7
Clinique D /ID# 247330
Laval, Quebec, H7N 6L2
Roula Rassi MD Inc /ID# 252563
Laval, Quebec, H7P 4K7
Fiona Lovegrove Medicine Professional Corporation /ID# 255784
London, Ontario, N6A 5R9
Lynde Institute for Dermatology /ID# 246341
Markham, Ontario, L3P 1X2
Allergy Research Canada Inc. /ID# 251916
Niagara Falls, Ontario, L2H 1H5
SKiN Centre for Dermatology /ID# 246291
Peterborough, Ontario, K9J 5K2
Diex Recherche Québec Inc. /ID# 247696
Québec, Quebec, G1V 4T3
Centre de Recherche St-Louis /ID# 252223
Québec, Quebec, G1W 4R4
York Dermatology Clinic and Research Centre /ID# 246921
Richmond Hill, Ontario, L4B 1L1
Dre Angelique Gagne-Henley M.D. inc. /ID# 246457
Saint-Jérôme, Quebec, J7Z 7E2
Dr. Chih-ho Hong Medical Inc. /ID# 246841
Surrey, British Columbia, V3R 6A7
Canadian Dermatology Centre /ID# 246334
Toronto, Ontario, M3B 0A7
FACET Dermatology /ID# 254914
Toronto, Ontario, M4C 1L1
AvantDerm, Toronto, CA /ID# 250941
Toronto, Ontario, M5A 3R6
Evidence based medical educator Inc. /ID# 246687
Toronto, Ontario, M5G 1E2
Sima Recherche inc. /ID# 248338
Verdun, Quebec, H4G 3E7
About this study
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
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.
Read more
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
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Upadacitinib | Participants receiving upadacitinib for moderate to severe atopic dermatitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 4
Secondary outcomes (29)
Percentage of Participants Achieving 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.
Measured: Up to 2 Months
Percentage of Participants Achieving vlGA-AD of ≥ 2 at baseline reaching a vIGA-AD score 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.
Measured: Up to 4 Months
Percentage of Participants with a vIGA score 0 or 1 at Baseline Maintaining a vIGA-AD score 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.
Measured: 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)
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: 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)
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Up to 4 Months
Absolute mean EASI score
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Up to 4 Months
Percent change in EASI score from baseline
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Up to 4 Months
Mean change in EASI score from baseline
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Up to 4 Months
Percent change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Up to 4 Months
Mean change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Up to 4 Months
Percent change in Worst pruritus numerical rating scale (WP-NRS) score from baseline
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Measured: Up to 4 Months
Mean change in WP-NRS score from baseline
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Measured: Up to 4 Months
Percentage of Participants with WP-NRS >2 at baseline achieving a WP-NRS score of 0 or 1
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Measured: Up to 4 Months
Percentage of Participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Measured: Up to 4 Months
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
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Measured: Up to 4 Months
Absolute mean DLQI scores
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Measured: Up to 4 Months
Percent change in DLQI score from Baseline
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Measured: Up to 4 Months
Mean change in DLQI score from Baseline
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Measured: Up to 4 Months
Absolute mean Patient Oriented Eczema Measurement (POEM) score
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Measured: Up to 4 Months
Percent change in POEM score from baseline
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Measured: Up to 4 Months
Mean change in POEM score from baseline
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Measured: Up to 4 Months
Percentage of Participants with a baseline POEM score ≥ 4 achieving an improvement (reduction) in POEM ≥ 4 at Month 4
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Measured: Up to 4 Months
Percentage of Participants achieving a POEM score of ≤2 among participants with POEM >2 at baseline
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Participants respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Measured: Up to 4 Months
Percent change in Body surface area (BSA) score from baseline
The investigator selects the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus five digits is assumed to be approximately equivalent to 1%. Measurement of the total area of involvement by the investigator is aided by imagining if scattered plaques were moved so that they were next to each other and then estimating the total area involved. Published score bands: 0% (clear), 0.1-15.9% (mild), 16.0-39.9% (moderate), 40-100% (severe).
Measured: Up to 4 Months
Mean change in BSA score from baseline
The investigator selects the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus five digits is assumed to be approximately equivalent to 1%. Measurement of the total area of involvement by the investigator is aided by imagining if scattered plaques were moved so that they were next to each other and then estimating the total area involved. Published score bands: 0% (clear), 0.1-15.9% (mild), 16.0-39.9% (moderate), 40-100% (severe).
Measured: Up to 4 Months
Percentage of Participants who are "Very much improved" or "Much improved" on the Patient Global Impression of Change (PGIC)
The PGIC ask participants to rate the overall change in their AD symptoms using a 7-point response scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. PGIC score ranges from 1 to 7 with lower score desirable.
Measured: Up to 4 Months
Percentage of Participants who report symptoms to be "Minimal" or "Absent" on the Patient Global Impression of Severity (PGIS)
The PGIS ask participants to describe the severity of their AD symptoms at the present time using a 7-point response scale: 0= Absent, 1 = Minimal, 2 = Mild, 3 = Moderate, 4= Moderately Severe, 5 = Severe, 6 = Very Severe.
Measured: Up to 4 Months
Percentage of Participants who report symptoms to be "Very satisfied" or "Extremely satisfied" on the Patient Global Impression of Treatment (PGIT)
PGIT-AD is a single item participant self-administered instrument designed to assess participant satisfaction or dissatisfaction with their current treatment for atopic dermatitis based on the following question: "Overall, how satisfied or dissatisfied are you with your current treatment for atopic dermatitis?". Response options range from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Measured: Up to 4 Months
Number of participants who used concomitant AD medications along with upadacitinib since last visit
Number of participants who used concomitant AD medications since last visit.
Measured: Up to 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394792
- Sponsor's protocol ID
- P23-106
- Acronym
- CAN UpTIMISE
- Status last verified
- Aug 2025
- First submitted
- 25 May 2022
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prajapati VH, Jain V, Gooderham MJ, Cecchini M, Lee JK, Lynde CW, Grewal P, Ferrier A, Prefontaine D, Sterling C, Chih-Ho Hong H. Real-World Evidence of Upadacitinib in Atopic Dermatitis after Inadequate Response or Intolerance to Dupilumab: The CAN UpTIMISE Study. Dermatol Ther (Heidelb). 2026 Sep 11. doi: 10.1007/s13555-026-01907-7. Online ahead of print.
PubMed 42728527
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05394792
- Acronym / sponsor ID
- CAN UpTIMISE / P23-106
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis (AD), Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Upadacitinib | – | –Participants receiving upadacitinib for moderate to severe atopic dermatitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- Availability of medication history during the past 4 weeks prior to baseline visit
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
Time frame: Month 4
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.
29 secondary outcomes
Percentage of Participants Achieving vlGA-AD of 0 or 1
Time frame: Up to 2 Months
Percentage of Participants Achieving vlGA-AD of ≥ 2 at baseline reaching a vIGA-AD score of 0 or 1
Time frame: Up to 4 Months
Percentage of Participants with a vIGA score 0 or 1 at Baseline Maintaining a vIGA-AD score 0 or 1
Time frame: 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)
Time frame: 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)
Time frame: Up to 4 Months
Absolute mean EASI score
Time frame: Up to 4 Months
Percent change in EASI score from baseline
Time frame: Up to 4 Months
Mean change in EASI score from baseline
Time frame: Up to 4 Months
Percent change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])
Time frame: Up to 4 Months
Mean change in EASI score by body region (head and neck region, trunk [including genitals], upper limbs, and lower limbs [including buttocks])
Time frame: Up to 4 Months
Percent change in Worst pruritus numerical rating scale (WP-NRS) score from baseline
Time frame: Up to 4 Months
Mean change in WP-NRS score from baseline
Time frame: Up to 4 Months
Percentage of Participants with WP-NRS >2 at baseline achieving a WP-NRS score of 0 or 1
Time frame: Up to 4 Months
Percentage of Participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1
Time frame: Up to 4 Months
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
Time frame: Up to 4 Months
Absolute mean DLQI scores
Time frame: Up to 4 Months
Percent change in DLQI score from Baseline
Time frame: Up to 4 Months
Mean change in DLQI score from Baseline
Time frame: Up to 4 Months
Absolute mean Patient Oriented Eczema Measurement (POEM) score
Time frame: Up to 4 Months
Percent change in POEM score from baseline
Time frame: Up to 4 Months
Mean change in POEM score from baseline
Time frame: Up to 4 Months
Percentage of Participants with a baseline POEM score ≥ 4 achieving an improvement (reduction) in POEM ≥ 4 at Month 4
Time frame: Up to 4 Months
Percentage of Participants achieving a POEM score of ≤2 among participants with POEM >2 at baseline
Time frame: Up to 4 Months
Percent change in Body surface area (BSA) score from baseline
Time frame: Up to 4 Months
Mean change in BSA score from baseline
Time frame: Up to 4 Months
Percentage of Participants who are "Very much improved" or "Much improved" on the Patient Global Impression of Change (PGIC)
Time frame: Up to 4 Months
Percentage of Participants who report symptoms to be "Minimal" or "Absent" on the Patient Global Impression of Severity (PGIS)
Time frame: Up to 4 Months
Percentage of Participants who report symptoms to be "Very satisfied" or "Extremely satisfied" on the Patient Global Impression of Treatment (PGIT)
Time frame: Up to 4 Months
Number of participants who used concomitant AD medications along with upadacitinib since last visit
Time frame: Up to 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Derived from this study: PubMed 42728527Prajapati VH, Jain V, Gooderham MJ, Cecchini M, Lee JK, Lynde CW, Grewal P, Ferrier A, Prefontaine D, Sterling C, Chih-Ho Hong H. Real-World Evidence of Upadacitinib in Atopic Dermatitis after Inadequate Response or Intolerance to Dupilumab: The CAN UpTIMISE Study. Dermatol Ther (Heidelb). 2026 Sep 11. doi: 10.1007/s13555-026-01907-7. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by AbbVie at 25 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.