Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (JADE Compare)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Immune System Diseases; Hypersensitivity; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Dermatitis; Eczema; Skin Diseases, Eczematous; Dermatitis, Atopic
• Intervention / Treatment: Drug: PF-04965842 100 mg; Drug: Injectable Placebo; Drug: PF-04965842 200 mg; Drug: Dupilumab; Drug: Oral Placebo

• Study Type: Interventional
• Enrollment (Actual): 838
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Australian Clinical Research Network
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • South Australia
    • Hectorville, South Australia, Australia, 5073
      • North Eastern Health Specialists
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • Carlton, Victoria, Australia, 3053
      • Skin and Cancer Foundation Inc
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Bulgaria
  • Sofia, Bulgaria, 1431
    • "DCC Aleksandrovska" EOOD
  • Sofia, Bulgaria, 1784
    • "Mc Synexus Sofia" Eood
  • Sofia, Bulgaria, 1000
    • DCC 2/Sofia EOOD
  • Sofia, Bulgaria, 1756
    • Dermatology Clinic "Sofia" Ltd
  • Stara Zagora, Bulgaria, 6000
    • Medical Centre Synexus Sofia EOOD-branch Stara Zagora
  • Varna, Bulgaria, 9000
    • "DCC "Mladost-M Varna" OOD
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H4E1
      • Pacific Dermaesthetics Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M3Z4
      • Wiseman Dermatology Research Inc.
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dermeffects
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Peterborough, Ontario, Canada, K9J5K2
      • Skin Centre For Dermatology
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research (Toronto)
    • Toronto, Ontario, Canada, M3H5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M5A 3R6
      • AvantDerm Clinical Research
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4V1R9
      • Dr. Rachel Asiniwasis Medical Prof Corp
• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 7580206
      • Centro Medico SkinMed Limitada
    • Santiago, Region Metropolitana, Chile, 7640881
      • Clinica Dermacross S.A.
    • Santiago, Region Metropolitana, Chile, 8420383
      • Centro Internacional de Estudios Clinicos - CIEC
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile, 7750495
      • MIRES (M Y F Estudios Clínicos Limitada)
• Czechia
  • Nachod, Czechia, 547 01
    • Dermamedica S.R.O.
  • Ostrava, Czechia, 702 00
    • CCR Ostrava, s.r.o.
  • Pardubice, Czechia, 530 02
    • CCR Czech, a.s.
  • Pardubice, Czechia, 530 02
    • BENU Lekarna
  • Pardubice, Czechia, 532 03
    • Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie
  • Praha 1, Czechia, 11000
    • Sanatorium profesora Arenbergera
  • Praha 2, Czechia, 120 00
    • Lekarna U sv. Ignace
  • Praha 2, Czechia, 120 00
    • Synexus Czech, s.r.o.
  • Praha 3, Czechia, 130 00
    • CCR Prague, s.r.o.
• Germany
  • Augsburg, Germany, 86179
    • Licca Clinical Research Institute
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Bielefeld, Germany, 33647
    • Klinikum Bielefeld Rosenhöhe
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn AöR
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden GmbH
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
  • Frankfurt, Germany, 60596
    • IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung
  • Halle, Germany, 06120
    • Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Langenau, Germany, 89129
    • Studienzentrum Dr. med. Beate Schwarz
  • Leipzig, Germany, 04103
    • SIBAmed Studienzentrum GmbH & Co KG
  • Luebeck, Germany, 23538
    • Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
  • Mahlow, Germany, 15831
    • Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling
  • Marburg, Germany, 35043
    • Universitätsklinikum Marburg
  • Muenster, Germany, 48149
    • University of Muenster
• Hungary
  • Budapest, Hungary, 1085
    • SE AOK Bor-, Nemikortani es Boronkologiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyula, Hungary, 5700
    • Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS
  • Püspökladány, Hungary, 4150
    • Trial Pharma Kft.
  • Veszprem, Hungary, 8200
    • Medmare Bt
• Italy
  • Modena, Italy, 41124
    • AOU Policlinico di Modena, Struttura Complessa di Dermatologia
  • RM
    • Roma, RM, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
• Japan
  • Fukuoka, Japan, 814-0171
    • Hoshikuma Dermatology・Allergy Clinic
  • Fukuoka, Japan, 819-0167
    • Matsuda Tomoko Dermatological Clinic
  • Saitama, Japan, 330-0854
    • Sanrui Hifuka
  • Chiba
    • Ichikawa, Chiba, Japan, 272-0033
      • Kawashima Dermatology Clinic
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic
  • Hyogo
    • Kobe, Hyogo, Japan, 657-0846
      • Dermatology Shimizu Clinic
  • Kumamoto
    • Kamimashiki-gun, Kumamoto, Japan, 861-3101
      • Noguchi Dermatology Clinic
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Osaka Habikino Medical Center
    • Sakai, Osaka, Japan, 593-8324
      • Kume Clinic
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 102-0072
      • Iidabashi Skin Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Shinjyuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital CNUH
  • Incheon, Korea, Republic of, 21431
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei Univ. Health System
  • Seoul, Korea, Republic of, 06973
    • Chung-ang University Hospital
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584
      • Soon Chun Hyang University Bucheon Hospital
• Latvia
  • Riga, Latvia, LV-1001
    • Riga 1st Hospital, Clinic for Dermatology and STD
  • Riga, Latvia, LV-1003
    • Aesthetic dermatology clinic of Prof. J. Kisis
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Riga, Latvia, LV-1004
    • Childrens Clinical University Hospital State SLLC
  • Ventspils, Latvia, LV-3601
    • Outpatient Clinic Of Ventspils
• Mexico
  • Queretaro, Mexico, 76070
    • SMIQ. S. de R. L. de C.V.
  • Mexico CITY
    • Cuauhtemoc, Mexico CITY, Mexico, 06100
      • Cryptex Investigación Clínica, S.A. de C.V.
    • Cuauhtemoc, Mexico CITY, Mexico, 06700
      • ARKE Estudios Clínicos S.A. de C.V.
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64718
      • Eukarya Pharmasite S.C.
• Poland
  • Bialystok, Poland, 15-453
    • NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"
  • Chorzow, Poland, 41-500
    • Centrum Medyczne Sensemed
  • Czestochowa, Poland, 42-202
    • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  • Gdansk, Poland, 80-152
    • COPERNICUS-SZPITAL Oddzial Dermatologii
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
  • Gdynia, Poland, 81-537
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Grodzisk Mazowiecki, Poland, 05-825
    • MCBK
  • Katowice, Poland, 40-040
    • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-568
    • Care Clinic Centrum Medyczne
  • Kielce, Poland, 25-155
    • Gabinet Dermatologiczny Beata Krecisz
  • Krakow, Poland, 30-363
    • Centrum Medyczne PLEJADY
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Krakow, Poland, 31-302
    • AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
  • Ksawerow, Poland, 95-054
    • Prywatna Praktyka Lekarska - Adam Smialowski
  • Lodz, Poland, 90-436
    • Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
  • Lodz, Poland, 91-211
    • Salve Medica Sp. z o.o. Sp. k.
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne Lublin II
  • Lublin, Poland, 20-406
    • NZOZ "Med-Laser" Borzecki Spolka Jawna
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Dermedic Jacek Zdybski
  • Poznan, Poland, 60-702
    • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
  • Poznan, Poland, 60-848
    • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
  • Rybnik, Poland, 44-200
    • LIFT-MED Spolka Akcyjna
  • Rzeszow, Poland, 35-205
    • EMED Centrum Uslug Medycznych Ewa Smialek
  • Rzeszow, Poland, 35-055
    • Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp. z o.o.
  • Warszawa, Poland, 02-758
    • Klinika Ambroziak Sp. Z O.O.
  • Warszawa, Poland, 01-192
    • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Warszawa, Poland, 00-874
    • Medycyna Kliniczna
  • Warszawa, Poland, 02-691
    • "REUMATIKA - Centrum Reumatologii" NZOZ
  • Warszawa, Poland, 02-657
    • RCMed Oddzial Warszawa
  • Warszawa, Poland, 02-661
    • Carpe Diem Centrum Medycyny Estetycznej
  • Wroclaw, Poland, 50-381
    • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 50-220
    • EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
  • Wroclaw, Poland, 50-566
    • Lukasz Matusiak "4Health"
• Slovakia
  • Bratislava, Slovakia, 831 01
    • Summit Clinical Research, s.r.o.
  • Kosice, Slovakia, 04001
    • Pedi-Derma s.r.o.
  • Kosice-Saca, Slovakia, 040 15
    • Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica
  • Nove Zamky, Slovakia, 940 34
    • Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka klinika
  • Svidnik, Slovakia, 089 01
    • SANARE spol. s.r.o., Dermatovenerologicka ambulancia
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
    • Badalona, Barcelona, Spain, 08016
      • Hospital Universitari Germans Trias i Pujol
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro de Majadahonda
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung City, Taiwan, 40201
    • Chung Shan Medical University Hospital (CSMUH)
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taiwan (r.o.c)
    • Taipei, Taiwan (r.o.c), Taiwan, 11217
      • Taipei Veterans General Hospital
• United Kingdom
  • Corby, United Kingdom, NN18 9EZ
    • MeDiNova Northamptonshire Dedicated Research Centre
  • Glasgow, United Kingdom, G3 8SJ
    • West Glasgow ACH, NHS Greater Glasgow and Clyde
  • Berkshire
    • Wokingham, Berkshire, United Kingdom, RG40 1XS
      • Medinova Research -West London Dedicated Research Centre
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Derriford Hospital
  • Essex
    • Romford, Essex, United Kingdom, RM1 3PJ
      • Medinova Research, East London Dedicated Research Centre
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
  • Kent
    • Sidcup, Kent, United Kingdom, DA14 6LT
      • Medinova Research, South London Clinical Trial Centre
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • MeDiNova Research North London Dedicated Research Centre
  • Peterborough
    • Yaxley, Peterborough, United Kingdom, PE7 3JL
      • Medinova Research
  • WEST Yorkshire
    • Shipley, WEST Yorkshire, United Kingdom, BD18 3SA
      • Medinova, Yorkshire Quality Research Site
  • Warwickshire
    • Kenilworth, Warwickshire, United Kingdom, CV8 1JD
      • Medinova Research, Warwickshire Dedicated Research Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama, LLC
  • California
    • Huntington Beach, California, United States, 92647
      • Marvel Research, LLC
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Long Beach, California, United States, 90808
      • Allergy & Asthma Care Center of Southern California
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California dba Southern California Research
    • Murrieta, California, United States, 92562
      • Dermatology Specialists, Inc.
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Santa Rosa, California, United States, 95405
      • Synexus Clinical Research US, Inc.
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
  • Florida
    • Cape Coral, Florida, United States, 33991
      • Renaissance Research and Medical Group, Inc
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education, LLC
    • Coral Gables, Florida, United States, 33134
      • C & R Research Services USA, Inc
    • Doral, Florida, United States, 33166
      • Moonshine Research Center, Inc.
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research, Inc.
    • Largo, Florida, United States, 33770
      • Olympian Clinical Research
    • Miami, Florida, United States, 33126
      • Savin Medical Group LLC
    • Miami Lakes, Florida, United States, 33016
      • Wellness Clinical Research, LLC
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of the southeast, LLC
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of SouthEast, LLC
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Idaho Allergy and Research
    • Nampa, Idaho, United States, 83687
      • ASR, LLC
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Normal, Illinois, United States, 61761
      • Midwest Allergy Sinus Asthma, SC
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Forefront Dermatology, S.C.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research, LLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialists of NY and NJ
  • New York
    • Kew Gardens, New York, United States, 11374
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10022
      • Juva Skin and Laser Center
    • Oceanside, New York, United States, 11572
      • TrialSpark, Inc (Russell Cohen)
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
    • Cary, North Carolina, United States, 27511
      • Cary Dermatology Center, PA
    • Greensboro, North Carolina, United States, 27408
      • Medication Management, LLC
    • Statesville, North Carolina, United States, 28625
      • PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
    • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem Dermatology and Surgery Center, PLLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Newton Clinical Research
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Portland Clinical Research dba Columbia Allergy & Asthma Clinic
    • Medford, Oregon, United States, 97504
      • Crisor, LLC
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University (OHSU)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co, Inc.
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc.
    • Greer, South Carolina, United States, 29651
      • Synexus Clinical Research US. Inc.
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Austin, Texas, United States, 78705
      • Austin Institute for Clinical Research, Inc.
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD. LLP
  • Utah
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Dermatology Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology and Skin Cancer Center
    • Norfolk, Virginia, United States, 23518
      • Velocity Urgent Care

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:

• Male or female subjects aged 18 years or older at the time of informed consent
• Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
• Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study

• Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

  1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
  2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.

• Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure; or
  • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study

Exclusion Criteria:

• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
• Other active nonAD inflammatory skin diseases or conditions affecting skin
• Prior treatment with JAK inhibitors
• Previous treatment with dupilumab
• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg; Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20	Drug: PF-04965842 100 mg; PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;; In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.; Drug: Injectable Placebo; Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
Experimental: PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg; Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20	Drug: Injectable Placebo; Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.; Drug: PF-04965842 200 mg; PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;; In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.
Active Comparator: Dupilumab Injection + Oral Placebo followed by Oral Placebo; Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20	Drug: Dupilumab; Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.; Drug: Oral Placebo; Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;; In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.
Placebo Comparator: Oral Placebo + Placebo Inj followed by 100 mg PF-04965842; Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20	Drug: PF-04965842 100 mg; PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;; In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.; Drug: Injectable Placebo; Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.; Drug: Oral Placebo; Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;; In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.
Placebo Comparator: Oral Placebo + Placebo Inj followed by 200 mg PF-04965842; Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20	Drug: Injectable Placebo; Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.; Drug: PF-04965842 200 mg; PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;; In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.; Drug: Oral Placebo; Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;; In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12	IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 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. Assessment excluded scalp, palms and sole.	Baseline (the last measurement prior to first dosing on Day 1), Week 12
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12	EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16	Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.	Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16	IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 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. Assessment excluded sole, palms and scalp.	Baseline, Week 2, 4, 8 and 16
Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Week 2, 4, 8 and 16
Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Week 2, 4, 8, 12 and 16
Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Week 2, 4, 8,12 and 16
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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, higher scores = greater severity of AD.	Baseline, Week 2, 4, 8, 12 and 16
Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS	Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.	Baseline up to Week 16
Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated 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. Maximum 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: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.	Baseline, Week 2, 4, 8, 12 and 16
Percentage BSA at Week 18 and 20	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated 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. Maximum 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: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.	Week 18 and 20
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16	Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.	Baseline, Week 2, 4, 8, 12 and 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16	DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions 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.	Baseline, Week 2, 12 and 16
DLQI at Week 20	DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions 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 20
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16	EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.	Baseline, Week 12 and 16
Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16	EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.	Baseline, Week 12 and 16
EQ-5D-5L- Index Value at Week 20	EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.	Week 20
EQ-5D-5L- VAS Score at Week 20	EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.	Week 20
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16	HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.	Baseline, Weeks 12 and 16
Change From Baseline in HADS - Depression Scale at Week 12 and 16	HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.	Baseline, Week 12 and 16
HADS - Anxiety Scale at Week 20	HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.	Week 20
HADS - Depression Scale at Week 20	HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.	Week 20
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16	POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.	Baseline, Week 12 and 16
POEM at Week 20	POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.	Week 20
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16	PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.	Baseline, Week 1 to Week 16
PSAAD Total Score at Week 18 and 20	PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.	Week 18 and 20
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.	Baseline, Week 2, 4, 8 12 and 16
Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.	Baseline, Week 2, 4, 8 12 and 16
Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.	Baseline, Week 2, 4, 8 12 and 16
SCORAD VAS of Itch and Sleep Loss at Week 18 and 20	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.	Week 18 and 20
Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16	Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.	Baseline up to Week 16

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18. Erratum In: Am J Clin Dermatol. 2021 Nov;22(6):905.
• Reich K, Lio PA, Bissonnette R, Alexis AF, Lebwohl MG, Pink AE, Kabashima K, Boguniewicz M, Nowicki RJ, Valdez H, Zhang F, DiBonaventura M, Cameron MC, Clibborn C. Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2022 Sep 13:S2213-2198(22)00926-6. doi: 10.1016/j.jaip.2022.08.042. Online ahead of print.
• Alexis A, de Bruin-Weller M, Weidinger S, Soong W, Barbarot S, Ionita I, Zhang F, Valdez H, Clibborn C, Yin N. Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study. Dermatol Ther (Heidelb). 2022 Mar;12(3):771-785. doi: 10.1007/s13555-022-00694-1. Epub 2022 Mar 17.
• Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H. Comparing abrocitinib and dupilumab in the treatment of atopic dermatitis: a plain language summary. Immunotherapy. 2022 Jan;14(1):5-14. doi: 10.2217/imt-2021-0224. Epub 2021 Nov 15.
• Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H; JADE COMPARE Investigators. Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis. N Engl J Med. 2021 Mar 25;384(12):1101-1112. doi: 10.1056/NEJMoa2019380.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; atopic eczema; JAK; janus kinase
• Additional Relevant MeSH Terms: Hypersensitivity; Dermatitis; Eczema; Skin Diseases; Dermatitis, Atopic; Immune System Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity, Immediate; Skin Diseases, Eczematous; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: B7451029; COMPARE (Other Identifier: Alias Study Number); 2018-002573-21 (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: No