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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03738397
Registration number
NCT03738397
Ethics application status
Date submitted
9/11/2018
Date registered
13/11/2018
Date last updated
15/03/2024
Titles & IDs
Public title
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
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Scientific title
A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
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Secondary ID [1]
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2018-002264-57
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Secondary ID [2]
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M16-046
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Universal Trial Number (UTN)
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Trial acronym
Heads Up
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Upadacitinib
Other interventions - Dupilumab
Treatment: Drugs - Placebo to dupilumab
Treatment: Drugs - Placebo to upadacitinib
Experimental: Upadacitinib 30 mg QD - Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
Experimental: Dupilumab 300 mg EOW - Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.
Other interventions: Upadacitinib
Extended release tablet
Other interventions: Dupilumab
Dupilumab is administered as a subcutaneous (SC) injection
Treatment: Drugs: Placebo to dupilumab
Placebo administered as a subcutaneous injection
Treatment: Drugs: Placebo to upadacitinib
Tablet
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [1]
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Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16
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Assessment method [1]
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The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
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Timepoint [1]
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Baseline (Week 0) to Week 16
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Secondary outcome [2]
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Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [3]
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Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Week 16
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Secondary outcome [4]
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Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4
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Assessment method [4]
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The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
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Timepoint [4]
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Baseline (Week 0) to Week 4
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Secondary outcome [5]
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Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 2
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Secondary outcome [6]
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Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1
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Assessment method [6]
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The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
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Timepoint [6]
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Baseline (Week 0) to Week 1
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Secondary outcome [7]
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Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 16
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Assessment method [7]
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The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
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Timepoint [7]
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Baseline and Week 16
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Eligibility
Key inclusion criteria
- Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
Area and Severity Index (EASI) = 16, Investigator's Global Assessment (IGA) = 3, = 10%
body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and
Baseline weekly average of daily Worst Pruritus NRS = 4.
- Participant is a candidate for systemic therapy or have recently required systemic
therapy for AD.
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Minimum age
18
Years
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Maximum age
76
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant has prior exposure to Janus Kinase (JAK) inhibitor.
- Participant has prior exposure to dupilumab.
- Participant is unable or unwilling to discontinue current AD treatments prior to the
study.
- Participant has requirement of prohibited medications during the study.
- Participant has other active skin diseases or skin infections requiring systemic
treatment or would interfere with appropriate assessment of AD lesions.
- Female participant who is pregnant, breastfeeding, or considering pregnancy during the
study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/12/2020
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Sample size
Target
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Accrual to date
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Final
673
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Holdsworth House Medical Practice /ID# 214565 - Darlinghurst
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Recruitment hospital [2]
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The Skin Hospital /ID# 214401 - Darlinghurst
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Recruitment hospital [3]
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Veracity Clinical Research /ID# 211134 - Woolloongabba
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Recruitment hospital [4]
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Sinclair Dermatology /ID# 209395 - East Melbourne
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Recruitment hospital [5]
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Burswood Dermatology /ID# 214875 - Victoria Park
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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6100 - Victoria Park
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Recruitment outside Australia
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Valencia
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Country [97]
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Spain
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State/province [97]
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Pontevedra
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Country [98]
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Sweden
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State/province [98]
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Skane Lan
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Country [99]
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Sweden
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State/province [99]
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Stockholm
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Country [100]
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Taiwan
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State/province [100]
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Taichung
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Country [101]
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Taiwan
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State/province [101]
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Taipei
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Country [102]
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Taiwan
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State/province [102]
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Taichung City
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Country [103]
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Ukraine
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State/province [103]
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Zaporizka Oblast
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Country [104]
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Ukraine
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State/province [104]
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Kyiv
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Country [105]
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Ukraine
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State/province [105]
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Rivne
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Country [106]
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United Kingdom
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State/province [106]
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Brighton And Hove
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Country [107]
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United Kingdom
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State/province [107]
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Fife
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Country [108]
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United Kingdom
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State/province [108]
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Glasgow City
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Country [109]
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United Kingdom
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State/province [109]
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London, City Of
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Country [110]
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United Kingdom
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State/province [110]
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Wales
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
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Summary
Brief summary
This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with
moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03738397
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03738397
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