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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04345367




Registration number
NCT04345367
Ethics application status
Date submitted
27/03/2020
Date registered
14/04/2020

Titles & IDs
Public title
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Scientific title
A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Secondary ID [1] 0 0
2019-004013-13
Secondary ID [2] 0 0
B7451050
Universal Trial Number (UTN)
Trial acronym
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
Description of intervention(s) / exposure
Treatment: Drugs - Abrocitinib 200 mg
Other interventions - Dupilumab 300 mg

Experimental: Abrocitinib 200 mg plus placebo injection - Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24

Active comparator: Dupilumab 300 mg plus placebo tablets - Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26


Treatment: Drugs: Abrocitinib 200 mg
Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.

Other interventions: Dupilumab 300 mg
Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2
Timepoint [1] 0 0
Week 2
Primary outcome [2] 0 0
Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4
Timepoint [2] 0 0
Week 4
Secondary outcome [1] 0 0
Percentage of Participants Achieving EASI-90 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26
Timepoint [2] 0 0
Week 2, 8, 12, 20 and 26
Secondary outcome [3] 0 0
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26
Timepoint [3] 0 0
Week 2, 4, 8, 12, 16, 20 and 26
Secondary outcome [4] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26
Timepoint [4] 0 0
Week 2, 4, 8, 12, 16, 20 and 26
Secondary outcome [5] 0 0
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15
Timepoint [5] 0 0
Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Secondary outcome [6] 0 0
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26
Timepoint [6] 0 0
Week 4, 8, 12, 16, 20 and 26
Secondary outcome [7] 0 0
Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)
Timepoint [7] 0 0
Baseline (Day 1) up to Week 30
Secondary outcome [8] 0 0
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26
Timepoint [8] 0 0
Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Secondary outcome [9] 0 0
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26
Timepoint [9] 0 0
Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Secondary outcome [10] 0 0
Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26
Timepoint [10] 0 0
Baseline (Day 1), Week 12, 16 and 26
Secondary outcome [11] 0 0
Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26
Timepoint [11] 0 0
Baseline (Day 1), Week 12, 16 and 26
Secondary outcome [12] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26
Timepoint [12] 0 0
Baseline (Day 1), Week 2, 12, 16, 20 and 26
Secondary outcome [13] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26
Timepoint [13] 0 0
Baseline (Day 1), Week 12, 16 and 26
Secondary outcome [14] 0 0
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26
Timepoint [14] 0 0
Baseline (Day 1), Week 12, 16 and 26
Secondary outcome [15] 0 0
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26
Timepoint [15] 0 0
Baseline (Day 1), Week 12, 16 and 26
Secondary outcome [16] 0 0
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26
Timepoint [16] 0 0
Baseline (Day 1), Week 2, 12, 16, 20 and 26
Secondary outcome [17] 0 0
Medicated Topical Background Therapy-free Days
Timepoint [17] 0 0
Day 1 up to Week 26
Secondary outcome [18] 0 0
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26
Timepoint [18] 0 0
Week 2, 12, 16, 20 and 26

Eligibility
Key inclusion criteria
* 18 years of age or older
* Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
* Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
* Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
* Have increased risk of developing venous thromboembolism
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
* Other active non-AD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

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
11/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/07/2021
Sample size
Target
Accrual to date
Final
727
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Emeritus Research - Camberwell
Recruitment hospital [5] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [7] 0 0
Melbourne Health Radiology - Pakrville
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Pakrville
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
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Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
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North Carolina
Country [16] 0 0
United States of America
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Oregon
Country [17] 0 0
United States of America
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Pennsylvania
Country [18] 0 0
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South Dakota
Country [19] 0 0
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Tennessee
Country [20] 0 0
United States of America
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Texas
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United States of America
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Utah
Country [22] 0 0
Bulgaria
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Dobrich
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Bulgaria
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Dupnitsa
Country [24] 0 0
Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
State/province [28] 0 0
Newfoundland and Labrador
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
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Canada
State/province [30] 0 0
Quebec
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Chile
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Region Metropolitana
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Chile
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Región Metropolitana
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Finland
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Tampere
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Finland
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Turku
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Germany
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Bad Bentheim
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Germany
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Bielefeld
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Germany
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Dresden
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Germany
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Frankfurt am Main
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Germany
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Gera
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Germany
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Langenau
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Germany
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Leipzig
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Muenster
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kaposvár
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Hungary
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Szeged
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Italy
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Roma
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Gyeonggi-do
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Gwangju
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Incheon
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Seoul
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Latvia
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Riga
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Latvia
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Ventspils
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Bialystok
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Chorzow
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Gdansk
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Grodzisk Mazowiecki
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Katowice
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Krakow
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Lodz
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Ostrowiec Swietokrzyski
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Poznan
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Szczecin
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Warszawa
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Wroclaw
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Zabrze
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Slovakia
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Bratislava
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Slovakia
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Nove Zamky
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Slovakia
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Svidnik
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pontevedra
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Taiwan
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Taiwan (r.o.c)
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Taiwan
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New Taipei City
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Taiwan
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Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04345367