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)

• ClinicalTrials.gov Identifier: NCT05394792
• Recruitment Status: Recruiting
• First Posted: May 27, 2022
• Last Update Posted: May 26, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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.

Condition or disease
Atopic Dermatitis

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: July 31, 2024
• Estimated Study Completion Date: July 31, 2024

Groups and Cohorts

Group/Cohort
Participants Receiving Upadacitinib; Participants receiving upadacitinib for moderate to severe atopic dermatitis.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Percentage of Participants Achieving vlGA-AD of 0 or 1 [ Time Frame: Up to 2 Months ]
   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.
2. 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 ]
   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.
3. 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 ]
   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.
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 ]

   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.

5. 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 ]

   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.

6. Absolute mean EASI score [ Time Frame: Up to 4 Months ]

   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.

7. Percent change in EASI score from baseline [ Time Frame: Up to 4 Months ]

   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.

8. Mean change in EASI score from baseline [ Time Frame: Up to 4 Months ]

   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.

9. 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 ]

   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.

10. 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 ]

    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.

11. Percent change in Worst pruritus numerical rating scale (WP-NRS) score from baseline [ Time Frame: Up to 4 Months ]
    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.
12. Mean change in WP-NRS score from baseline [ Time Frame: Up to 4 Months ]
    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.
13. Percentage of Participants with WP-NRS >2 at baseline achieving a WP-NRS score of 0 or 1 [ Time Frame: Up to 4 Months ]
    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.
14. Percentage of Participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 [ Time Frame: Up to 4 Months ]
    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.
15. 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 ]
    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.
16. Absolute mean DLQI scores [ Time Frame: Up to 4 Months ]
    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.
17. Percent change in DLQI score from Baseline [ Time Frame: Up to 4 Months ]
    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.
18. Mean change in DLQI score from Baseline [ Time Frame: Up to 4 Months ]
    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.
19. Absolute mean Patient Oriented Eczema Measurement (POEM) score [ Time Frame: Up to 4 Months ]
    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.
20. Percent change in POEM score from baseline [ Time Frame: Up to 4 Months ]
    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.
21. Mean change in POEM score from baseline [ Time Frame: Up to 4 Months ]
    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.
22. 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 ]
    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.
23. Percentage of Participants achieving a POEM score of ≤2 among participants with POEM >2 at baseline [ Time Frame: Up to 4 Months ]
    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.
24. Percent change in Body surface area (BSA) score from baseline [ Time Frame: Up to 4 Months ]
    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).
25. Mean change in BSA score from baseline [ Time Frame: Up to 4 Months ]
    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).
26. 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 ]
    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.
27. 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 ]
    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.
28. 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 ]
    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).
29. Number of participants who used concomitant AD medications along with upadacitinib since last visit [ Time Frame: Up to 4 Months ]
    Number of participants who used concomitant AD medications since last visit.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

Locations

Canada, Alberta

Dermatology Research Institute Inc. /ID# 246344; Recruiting

Calgary, Alberta, Canada, T2J 7E1

Laser Rejuvenation Clinics Edmonton D.T. Inc. /ID# 246298; Recruiting

Edmonton, Alberta, Canada, T5J 3S9

Alpha Clinic Research Inc. /ID# 248015; Recruiting

Edmonton, Alberta, Canada, T6X 0N9

Canada, British Columbia

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

Surrey, British Columbia, Canada, V3R 6A7

Canada, Ontario

Lynderm Research Inc. /ID# 246341; Recruiting

Markham, Ontario, Canada, L3P 1X2

Allergy Research Canada Inc. /ID# 251916; Recruiting

Niagara Falls, Ontario, Canada, L2H 1H5

SKIN Centre for Dermatology /ID# 246291; Recruiting

Peterborough, Ontario, Canada, K9J 5K2

York Dermatology Clinic and Research Centre /ID# 246921; Recruiting

Richmond Hill, Ontario, Canada, L4C 9M7

Canadian Dermatology Centre /ID# 246334; Recruiting

Toronto, Ontario, Canada, M3B 0A7

FACET Dermatology /ID# 254914; Recruiting

Toronto, Ontario, Canada, M4C 1L1

AvantDerm, Toronto, CA /ID# 250941; Recruiting

Toronto, Ontario, Canada, M5A 3R6

Evidence based medical educator Inc. /ID# 246687; Recruiting

Toronto, Ontario, Canada, M5G 1E2

Canada, Quebec

Dr. Isabelle Delorme Inc. /ID# 246296; Recruiting

Drummondville, Quebec, Canada, J2B 5L4

Clinique D /ID# 247330; Recruiting

Laval, Quebec, Canada, H7N 6L2

Roula Rassi MD Inc /ID# 252563; Recruiting

Laval, Quebec, Canada, H7P 4K7

Centre de Recherche St-Louis /ID# 252223; Recruiting

Quebec City, Quebec, Canada, G1W 4R4

Diex Recherche Québec Inc. /ID# 247696; Recruiting

Québec, Quebec, Canada, G1V 4T3

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

Saint-Jerome, Quebec, Canada, J7Z 7E2

Sima Recherche inc. /ID# 248338; Recruiting

Verdun, Quebec, Canada, H4G 3E7

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT05394792
• Other Study ID Numbers: P23-106
• First Posted: May 27, 2022
• Last Update Posted: May 26, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:

Atopic Dermatitis (AD); Upadacitinib; RINVOQ

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases