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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03738397
Registration number
NCT03738397
Ethics application status
Date submitted
9/11/2018
Date registered
13/11/2018
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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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Inflammatory and Immune System
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0
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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
Treatment: Other - Upadacitinib
Treatment: Other - 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.
Treatment: Other: Upadacitinib
Extended release tablet
Treatment: Other: 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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Treatment: Other
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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]
0
0
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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Spain
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Valencia
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Spain
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Pontevedra
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Sweden
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Skane Lan
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Sweden
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Stockholm
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Taichung
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Taipei
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Ukraine
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Zaporizka Oblast
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Ukraine
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Kyiv
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Ukraine
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Rivne
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Brighton And Hove
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United Kingdom
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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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Ethics approval
Ethics application status
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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/study/NCT03738397
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Trial related presentations / publications
Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023. Erratum In: JAMA Dermatol. 2022 Feb 1;158(2):219. doi: 10.1001/jamadermatol.2021.5451. JAMA Dermatol. 2022 Feb 1;158(2):219. doi: 10.1001/jamadermatol.2022.0056. JAMA Dermatol. 2024 Mar 1;160(3):370. doi: 10.1001/jamadermatol.2023.6395. JAMA Dermatol. 2024 Jul 24. doi: 10.1001/jamadermatol.2024.2673.
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/97/NCT03738397/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/97/NCT03738397/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, D...
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Results are available at
https://clinicaltrials.gov/study/NCT03738397