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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04345367
Ethics application status
Date submitted
27/03/2020
Date registered
14/04/2020
Date last updated
24/03/2021

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
Combination Product - 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.

Combination Product: 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
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Peak Pruritus Numerical Rating Scale (PP-NRS4) - Response based on achieving at least a 4-point improvement in the severity of PP-NRS4 from baseline at Week 2
Timepoint [1] 0 0
Change from Baseline to Week 2
Primary outcome [2] 0 0
Change in Eczema Area and Severity Index (EASI) - Response based on achieving the EASI-90 (=90% improvement from baseline) at Week 4
Timepoint [2] 0 0
Change from Baseline to Week 4
Secondary outcome [1] 0 0
Change in Eczema Area and Severity Index (EASI) - Response based on achieving the EASI-90 (=90% improvement from baseline) at Week 16
Timepoint [1] 0 0
Change from Baseline to Week 16
Secondary outcome [2] 0 0
Change in Eczema Area and Severity Index (EASI) - Response based on achieving a 90% improvement in the EASI total score (EASI-90) at all scheduled time points up to Week 26
Timepoint [2] 0 0
Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26
Secondary outcome [3] 0 0
Change in Eczema Area and Severity Index (EASI) - Response based on achieving a =75% improvement in the EASI total score (EASI-75) at all other scheduled time points up to Week 26
Timepoint [3] 0 0
Change from Baseline to Week 2, Week 8, Week 12, Week 20, Week 26
Secondary outcome [4] 0 0
Change in Investigator's Global Assessment (IGA) - Response based on Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of =2 points at all scheduled time points up to Week 26
Timepoint [4] 0 0
Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26
Secondary outcome [5] 0 0
Change in Peak Pruritus Numerical Rating Scale (PP-NRS4) - Response based on achieving at least a 4-point improvement in the severity of PP-NRS4 from baseline at all scheduled time points except Week 2
Timepoint [5] 0 0
Change from Baseline to Week 4, Week 8, Week 16, Week 20, Week 26, Week 30
Secondary outcome [6] 0 0
Change in Peak Pruritus Numerical Rating Scale (PP-NRS4) - Time from baseline to achieve at least a 4-point improvement in the severity of PP-NRS4 scale
Timepoint [6] 0 0
Change from Baseline to Week 30
Secondary outcome [7] 0 0
Change in Body Surface Area (BSA) - Percent Change from Baseline in the % Body Surface Area (BSA) affected at all scheduled time points
Timepoint [7] 0 0
Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 30
Secondary outcome [8] 0 0
Change in Scoring Atopic Dermatitis (SCORAD) - Percent Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) at all scheduled time points
Timepoint [8] 0 0
Change from Baseline to Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 30
Secondary outcome [9] 0 0
Change in Hospital Anxiety and Depression Scale (HADS) - Change from baseline in the HADS at all scheduled time points
Timepoint [9] 0 0
Change from Baseline to Week 12, Week 16, Week 26
Secondary outcome [10] 0 0
Change in Dermatology Life Quality Index (DLQI) - Change from baseline in DLQI at all scheduled time points
Timepoint [10] 0 0
Change from Baseline to Week 2, Week 12, Week 16, Week 20, Week 26, Week 30
Secondary outcome [11] 0 0
Change in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) - Change from baseline in EQ-5D-5L at all scheduled time points
Timepoint [11] 0 0
Change from Baseline to Week 12, Week 16, Week 26, Week 30
Secondary outcome [12] 0 0
Change in Patient-Oriented Eczema Measure (POEM) - Change from baseline in POEM at all scheduled time points
Timepoint [12] 0 0
Change from Baseline to Week 12, Week 16, Week 26
Secondary outcome [13] 0 0
Change in Medical Outcomes Study - Sleep Scale (MOS Sleep Scale) - Change from baseline in MOS Sleep Scale at all scheduled time points
Timepoint [13] 0 0
Change from Baseline to Week 12, Week 16, Week 26
Secondary outcome [14] 0 0
Change in Skin Pain Numerical Rating Scale (NRS) - Change from baseline in Skin Pain NRS at all scheduled time points
Timepoint [14] 0 0
Change from Baseline to Week 2, Week 12, Week 16, Week 20, Week 26
Secondary outcome [15] 0 0
Medicated topical background therapy-free days - Medicated topical background therapy-free days
Timepoint [15] 0 0
Baseline to Week 30

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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 - 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
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
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State/province [18] 0 0
South Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
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
State/province [25] 0 0
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
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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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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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Dresden
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Frankfurt am Main
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Gera
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Langenau
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Leipzig
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Lübeck
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Mainz
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Muenster
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Budapest
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Debrecen
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Kaposvár
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Roma
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Gwangju
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Incheon
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Riga
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Ventspils
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Bialystok
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Chorzow
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Krakow
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Lodz
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Poznan
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Nove Zamky
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Svidnik
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Spain
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Barcelona
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Pontevedra
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Taiwan
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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
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to
assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally
QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as
per label guidelines) in adult participants on background topical therapy, with moderate to
severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will
be enrolled from approximately 220 sites globally. Approximately 600 participants will be
randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and
Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints
will be assessed throughout the entire study. Exploratory endpoints related to hand eczema
efficacy will be assessed throughout the study.
Trial website
https://clinicaltrials.gov/show/NCT04345367
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

Summary results
Other publications