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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
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
Secondary ID [1] 0 0
2018-002264-57
Secondary ID [2] 0 0
M16-046
Universal Trial Number (UTN)
Trial acronym
Heads Up
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional(has expanded access)
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16
Timepoint [1] 0 0
Baseline (Week 0) to Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4
Timepoint [4] 0 0
Baseline (Week 0) to Week 4
Secondary outcome [5] 0 0
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2
Timepoint [5] 0 0
Baseline and Week 2
Secondary outcome [6] 0 0
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1
Timepoint [6] 0 0
Baseline (Week 0) to Week 1
Secondary outcome [7] 0 0
Percentage of Participants Achieving a Reduction of = 4 Points From Baseline in Worst Pruritus NRS at Week 16
Timepoint [7] 0 0
Baseline and Week 16

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.
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2020
Sample size
Target
Accrual to date
Final
673
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice /ID# 214565 - Darlinghurst
Recruitment hospital [2] 0 0
The Skin Hospital /ID# 214401 - Darlinghurst
Recruitment hospital [3] 0 0
Veracity Clinical Research /ID# 211134 - Woolloongabba
Recruitment hospital [4] 0 0
Sinclair Dermatology /ID# 209395 - East Melbourne
Recruitment hospital [5] 0 0
Burswood Dermatology /ID# 214875 - Victoria Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6100 - Victoria Park
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Ukraine
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Ukraine
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Kyiv
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Ukraine
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Rivne
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United Kingdom
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Brighton And Hove
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Fife
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Glasgow City
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London, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, D... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03738397