Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Abrocitinib 200 mg; Combination product: Dupilumab 300 mg

• Study Type: Interventional
• Enrollment (Actual): 727
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology and Skin Cancer Centre
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc.
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Pakrville, Victoria, Australia, 3050
      • Melbourne Health Radiology
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
• Bulgaria
  • Dobrich, Bulgaria, 9300
    • MHAT Dobrich AD
  • Dupnitsa, Bulgaria, 2600
    • MC Asklepii OOD
  • Sofia, Bulgaria, 1431
    • DCC Alexandrovska EOOD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy MHAT Sofia
  • Sofia, Bulgaria, 1463
    • DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD
• Canada
  • Quebec, Canada, G1W4R4
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1V 4X7
    • Centre De Recherche Dermatologique Du Quebec Metropolitain
  • Alberta
    • Calgary, Alberta, Canada, T2J7E1
      • Dermatology Research Institute
    • Edmonton, Alberta, Canada, T6G1C3
      • Alberta DermaSurgery Centre
    • Red Deer, Alberta, Canada, T4P-1K4
      • CARE Clinic Ltd
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials, Inc.
  • Ontario
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research
    • London, Ontario, Canada, N6H 5L5
      • DermEffects
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge Research
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre for Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Sudbury, Ontario, Canada, P3C 1X8
      • Sudbury Skin Clinique
    • Sudbury, Ontario, Canada, P3A 1W8
      • Medicor Research Inc
    • Toronto, Ontario, Canada, M3H5Y8
      • Toronto Research Centre
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • Intermed groupe santé
• Chile
  • Region Metropolitana
    • Las Condes, Santiago, Region Metropolitana, Chile, 7580150
      • Medicien
    • Nunoa, Santiago, Region Metropolitana, Chile, 7750495
      • MIRES (M Y F Estudios Clínicos Limitada)
    • Nunoa, Santiago, Region Metropolitana, Chile, 7750495
      • Vida lntegra
    • Santiago, Region Metropolitana, Chile, 7500906
      • Centro Radiologico Plaza Baquedano
    • Santiago, Region Metropolitana, Chile, 8380456
      • Hospital Clinico Universidad de Chile
    • Santiago, Region Metropolitana, Chile, 7580206
      • Centro Medico SkinMed Limitada
    • Santiago, Region Metropolitana, Chile, 8420383
      • Centro Internacional de Estudios Clinicos - CIEC
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile, 7640881
      • Clinica Dermacross S.A.
• Finland
  • Tampere, Finland, 33100
    • Terveystalo Tampere
  • Turku, Finland, 20520
    • Mehiläinen Neo
  • Turku, Finland, 20520
    • Turun yliopistollinen keskussairaala
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Bielefeld, Germany, 33647
    • Klinikum Bielefeld Rosenhöhe
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden GmbH
  • Frankfurt am Main, Germany, 60596
    • IKF Pneumologie GmbH & Co KG
  • Gera, Germany, 07548
    • Srh Wald-Klinikum Gera Gmbh
  • Langenau, Germany, 89129
    • Studienzentrum Dr. med. Beate Schwarz
  • Leipzig, Germany, 04103
    • SIBAmed GmbH
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Mainz, Germany, 55128
    • Dermatologische Gemeinschaftspraxis Dres. Quist
  • Muenster, Germany, 48149
    • University of Muenster
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kaposvár, Hungary, 7400
    • Trial Pharma Kft.
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of, 21431
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
• Latvia
  • Riga, Latvia, LV-1003
    • Health Centre 4 Ltd. Diagnostics Centre
  • Riga, Latvia, LV-1003
    • LLC J.Kisis
  • Ventspils, Latvia, LV-3601
    • Outpatient Clinic Of Ventspils
• Poland
  • Bialystok, Poland, 15-453
    • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
  • Chorzow, Poland, 41-500
    • DERMAPOLIS Medical Dermatology Center
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Grodzisk Mazowiecki, Poland, 05-825
    • MCBK
  • Katowice, Poland, 40-568
    • Care Clinic Centrum Medyczne
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Lodz, Poland, 90-265
    • Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Dermedic Jacek Zdybski
  • Poznan, Poland, 61-441
    • Gabinety Lekarskie Rivermed
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Szczecin, Poland, 70-332
    • Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic"
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp. z o.o.
  • Warszawa, Poland, 00-874
    • Medycyna Kliniczna
  • Warszawa, Poland, 02-661
    • Carpe Diem Centrum Medycyny Estetycznej
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 50-566
    • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
  • Wroclaw, Poland, 50-220
    • EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
  • Zabrze, Poland, 41-800
    • Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
• Slovakia
  • Bratislava, Slovakia, 841 02
    • BeneDerma s.r.o.
  • Bratislava, Slovakia, 831 01
    • Summit Clinical Research, s.r.o.
  • Bratislava, Slovakia, 83103
    • SKINKLINIK s.r.o
  • Bratislava, Slovakia, 851 01
    • Derma therapy spol. s.r.o.
  • Nove Zamky, Slovakia, 940 34
    • Dermatovenerologicka ambulancia
  • Svidnik, Slovakia, 089 01
    • SANARE spol.s.r.o.
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Pontevedra, Spain, 36001
    • Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)
  • Pontevedra, Spain, 36071
    • Hospital de Montecelo
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
• Taiwan
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University-Shuang Ho Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taiwan (r.o.c)
    • Taipei City, Taiwan (r.o.c), Taiwan, 11217
      • Taipei Veterans General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin & Beauty Dermatology Center, PC
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology & MOHS Center, PC
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Long Beach, California, United States, 90806
      • Ark Clinical Research
    • Long Beach, California, United States, 90808
      • Beach Allergy and Asthma Specialty Group, A Medical Corporation
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group, Inc
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • San Diego, California, United States, 92123
      • University Clinical Trials Inc.
    • San Diego, California, United States, 92122
      • University of California San Diego Dermatology
    • San Francisco, California, United States, 94132
      • Synergy Dermatology
    • Santa Ana, California, United States, 92705
      • Wolverine Clinical Trials, Llc
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Llc
    • Largo, Florida, United States, 33770
      • Olympian Clinical Research
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Research, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32819
      • Accel Research Sites - Pure Skin Dermatology & Aesthetics
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida, Inc.
    • Tampa, Florida, United States, 33614
      • Olympian Clinical Research
    • West Palm Beach, Florida, United States, 33406
      • Integrated Clinical Research
  • Georgia
    • Norcross, Georgia, United States, 30093
      • One Health Research Clinic
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze & Itch Associates, LLC
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic Center for Research
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Epiphany Dermatology of Kansas, LLC
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Avant Research Associates, LLC
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • MetroBoston Clinical Partners, LLC
  • Michigan
    • Flint, Michigan, United States, 48507
      • Onyx Clinical Research
    • Flint, Michigan, United States, 48532
      • Linden Road Imaging Center
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Royal Oak, Michigan, United States, 48067
      • Regional Medical Imaging, P.C. ( Local X-Ray)
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Vivida Dermatology
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
  • North Carolina
    • Rocky Mount, North Carolina, United States, 27804
      • Boice-Willis Clinic, PA
    • Shelby, North Carolina, United States, 28150
      • Carolina Research Center, Inc.
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co, Inc.
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research - Tennessee LLC
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • Sugar Land, Texas, United States, 77479
      • Acclaim Dermatology, PLLC
  • Utah
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Dermatology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrocitinib 200 mg plus placebo injection; Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24	Drug: 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.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.	Week 2
Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4	EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving EASI-90 Response at Week 16	EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.	Week 16
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26	EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.	Week 2, 8, 12, 20 and 26
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26	EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.	Week 2, 4, 8, 12, 16, 20 and 26
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	IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting.	Week 2, 4, 8, 12, 16, 20 and 26
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15	The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.	Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26	The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.	Week 4, 8, 12, 16, 20 and 26
Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)	The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.	Baseline (Day 1) up to Week 30
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26	The extent (%) to which a body region was involved with AD was determined using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD.	Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26	SCORAD is a scoring index for AD which combined extent (A), severity (B) and subjective symptoms (C). For A, a rule of 9 was used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region was added to determine A (range: 0-100). B: severity of each sign (erythema; edema/papulation; oozing/crusting; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores were added to give B (range: 0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using visual analog scale (VAS) where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss were added to give 'C' (range: 0-20). SCORAD total score was calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26	HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety.	Baseline (Day 1), Week 12, 16 and 26
Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26	HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-D assessed the state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.	Baseline (Day 1), Week 12, 16 and 26
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26	DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.	Baseline (Day 1), Week 2, 12, 16, 20 and 26
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	The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.	Baseline (Day 1), Week 12, 16 and 26
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26	POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity.	Baseline (Day 1), Week 12, 16 and 26
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26	The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.	Baseline (Day 1), Week 12, 16 and 26
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26	The skin pain NRS was a participant reported outcome where participants were asked to rate the "worst skin pain" in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain.	Baseline (Day 1), Week 2, 12, 16, 20 and 26
Medicated Topical Background Therapy-free Days	Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.	Day 1 up to Week 26
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26	DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.	Week 2, 12, 16, 20 and 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs.	From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation	An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; a congenital anomaly/birth defect and other important medical events.	From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria	The pre-defined criteria for laboratory parameters included: hemoglobin (<9 grams per deciliter or decreases to >=2 below baseline); platelets (<75*10^3 cells per millimeter cube [mm^3]); lymphocytes (<0.5*10^3 cells per mm^3); neutrophils (<1*10^3 cells per mm^3); aspartate aminotransferase and alanine aminotransferase (>3* upper limit of normal).	From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Vital signs including temperature, systolic and diastolic blood pressure, and pulse rate were measured in a seated position after 5 minutes rest. Clinically significant change from baseline in vital signs were determined by the investigator.	From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data	A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator.	From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022 Jul 23;400(10348):273-282. doi: 10.1016/S0140-6736(22)01199-0.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; atopic eczema; JAK; janus kinase
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: B7451050; 2019-004013-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes