Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded 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: PF-04965842 200 mg; Drug: Placebo

Detailed Description

Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.

• Study Type: Interventional
• Enrollment (Actual): 1235
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • C.a.b.a, Argentina, C1425DKG
    • Psoriahue Medicina Interdisciplinaria
  • C.a.b.a., Argentina, C1027AAP
    • CINME Centro de Investigaciones Metabolicas
  • C.a.b.a., Argentina, C1055AAO
    • Buenos Aires Skin
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Framingham Centro Medico
    • Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
  • Santa FE
    • Rosario, Santa FE, Argentina, 2000
      • Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium, 1090
    • University Hospital Brussels
  • Edegem, Belgium, 2650
    • University Hospital Antwerp
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin Pesquisa Clinica
  • PR
    • Curitiba, PR, Brazil, 80030-110
      • CETI - Centro de Estudos em Terapias Inovadoras Ltda.
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22470-220
      • Instituto de Dermatologia e Estética do Brasil LTDA
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, RS, Brazil, 90160-093
      • Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
  • SP
    • Santo Andre, SP, Brazil, 09060-870
      • Fundacao do ABC - Faculdade de Medicina do ABC
    • Santo Andre, SP, Brazil, 09.080-110
      • Pesquisare Saude S/S Ltda
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • MC Asklepii" OOD
  • Gabrovo, Bulgaria, 5300
    • MHAT "Dr. Tota Venkova" AD
  • Sofia, Bulgaria, 1463
    • "DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
  • Sofia, Bulgaria, 1784
    • ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
  • Sofia, Bulgaria, 1404
    • "Center of skin-venereal diseases" EOOD, Sofia
  • Sofia, Bulgaria, 1784
    • "Mc Sinexus Sofia" Eood
  • Varna, Bulgaria, 9000
    • "ACIBADEM City Clinic Medical Center Varna" EOOD
• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
  • Alberta
    • Calgary, Alberta, Canada, T1Y0B4
      • Dermatology Research Institute
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical
    • Edmonton, Alberta, Canada, T6G1C3
      • Alberta Dermasurgery Center
  • 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
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge Research
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre For Dermatology
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Office of Dr. Paul Adam
    • Toronto, Ontario, Canada, M5A 3R6
      • AvantDerm
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research Inc.
• 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, 8380456
      • Hospital Clinico Universidad de Chile
• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Shanghai, China, 200443
    • Shanghai Dermatology Hospital
  • Shanghai, China, 200003
    • Shanghai Changzheng Hospital
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • The Second Affiliated Hospital of Army Medical University, PLA
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong - Shenzhen Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital With Nanjing University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • HuaShan Hospital Fudan University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital, Dermatological Department
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital/Dermatology Department
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
• Germany
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Berlin, Germany, 10247
    • Hautzentrum Friedrichshain Studien
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie
  • Bielefeld, Germany, 33647
    • Klinikum Bielefeld Rosenhoehe
  • Bonn, Germany, 53127
    • Universitaetsklinikum Bonn
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
  • Erlangen, Germany, 91054
    • Universitaetsklinikum Erlangen
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Halle, Germany, 06120
    • Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
  • Hamburg, Germany, 22391
    • MENSINGDERMA research GmbH
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany, 20537
    • TFS Trial Form Support GmbH
  • Hamburg, Germany, 22149
    • Katholisches Kinderkrankenhaus Wilhemstift
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Langenau, Germany, 89129
    • Praxis Dr. med. Beate Schwarz
  • Luebeck, Germany, 23538
    • Universitaetsklinikum Schleswig-Holstein
  • Stuttgart, Germany, 70178
    • Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
• Israel
  • Beer Sheva, Israel, 8410101
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat-Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Tel-Aviv, Israel, 6423906
    • Tel-Aviv Sourasky Medical Center
• Italy
  • Genova, Italy, 16132
    • Azienda Ospedaliero Universitaria San Martino di Genova
  • Milano, Italy, 20157
    • Ospedale Luigi Sacco
  • Modena, Italy, 41124
    • Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia
  • Rome, Italy, 00168
    • Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
  • BO
    • Bologna, BO, Italy, 40138
      • AOU Policlinico Sant'Orsola Malpighi
  • CH
    • Chieti, CH, Italy, 66100
      • Universita' degli Studi G. D'Annunzio -CeSi-MeT
  • RM
    • Roma, RM, Italy, 00144
      • IFO Istituto Dermatologico San Gallicano IRCCS,
  • Rome
    • Roma, Rome, Italy, 00167
      • Ospedale Cristo Re
• Latvia
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Riga, Latvia, LV - 1001
    • Riga 1st Hospital, Clinic of Dermatology and STD
  • Riga, Latvia, LV-1013
    • Health Centre 4 Ltd, Dermatology Clinics
  • Ventspils, Latvia, LV3601
    • Outpatient Clinic Of Ventspils
• Mexico
  • Aguascalientes, Mexico, 20127
    • Derma Norte del Bajio S.C
  • Chihuahua, Mexico, 31203
    • Centro de Investigacion Integral Medivest S.C.
  • Ciudad DE Mexico
    • Cuauhtemoc, Ciudad DE Mexico, Mexico, 06700
      • ARKE Estudios Clínicos S.A. de C.V.
  • Estado DE Mexico
    • Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
      • Phylasis Clinicas Research S. de R.L. de C.V.
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • JM Research SC
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Centro de Dermatologia de Monterrey
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum (UMC) Utrecht
• Poland
  • Bydgoszcz, Poland, 85-065
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Chorzow, Poland, 41-500
    • Centrum Medyczne Sensemed
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
  • Gdansk, Poland, 80-152
    • Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii
  • Katowice, Poland, 40-648
    • Pro Familia Altera Sp. Z O.O.
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-282
    • Silmedic Sp. z o.o., Oddzial w Katowicach
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Krakow, Poland, 30-348
    • Centrum Badan Klinicznych JCI
  • Krakow, Poland, 30-149
    • Malopolskie Centrum Kliniczne
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Lodz, Poland, 90-265
    • NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
  • Lodz, Poland, 90-349
    • O?rodek Bada? Klinicznych Appletreeclinics
  • Lodz, Poland, 90-436
    • Dermoklinika-Centrum Medyczne s.c.
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne Lublin II
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Dermedic Jacek Zdybski
  • Szczecin, Poland, 70-332
    • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
  • Tarnow, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
  • 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, 02-793
    • Etg Warszawa
  • Warszawa, Poland, 02-657
    • RCMed Oddzial Warszawa
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny, Klinika Dermatologiczna
  • Wroclaw, Poland, 50-381
    • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
  • Wroclaw, Poland, 50-566
    • Lukasz Matusiak "4Health'
  • Zabrze, Poland, 41-800
    • Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
• Romania
  • Bucuresti, Romania, 014142
    • SC Delta Health Care SRL
  • JUD. Brasov
    • Brasov, JUD. Brasov, Romania, 500283
      • SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
  • Jud. Cluj
    • Cluj-Napoca, Jud. Cluj, Romania, 400105
      • Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
  • Kemerovo, Russian Federation, 650070
    • Limited Liability Company "Medical Center "Rheuma-Med"
  • Kirov, Russian Federation, 610014
    • Clinic of FSBEI HE Kirov SMU MOH Russia
  • Moscow, Russian Federation, 107076
    • FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
  • Moscow, Russian Federation, 115478
    • NRC Institute of Immunology FMBA of Russia
  • Rostov-on-Don, Russian Federation, 344007
    • SBI RR "Skin and Venereal Dispensary"
  • Ryazan, Russian Federation, 390046
    • SBI RR "Regional Clinical Skin and Veneral Dispensary"
  • Saint Petersburg, Russian Federation, 196084
    • Medical Research Institute, LLC
  • Saint-Petersburg, Russian Federation, 191123
    • LLC "Pierre Wolkenstein Clinic of Skin Diseases"
  • Saint-Petersburg, Russian Federation, 191123
    • Vitiligo center
  • Saint-Petersburg, Russian Federation, 194100
    • FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
  • Saint-Petersburg, Russian Federation, 197022
    • FSBEI HE I.P.Pavlov SPbSMU MOH Russia
  • Saint-Petersburg, Russian Federation, 195257
    • Limited Liability Company "Sanavita"
  • Saint-Petersburg, Russian Federation, 194021
    • SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"
  • Smolensk, Russian Federation, 214018
    • RSBIH "Smolensk Regional Clinical Hospital"
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Nis, Serbia, 18000
    • Clinical Centre Nis
  • Pancevo, Serbia, 26000
    • General Hospital Pancevo
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
  • Bratislava, Slovakia, 841 02
    • BeneDerma s.r.o.
  • Bratislava, Slovakia, 85101
    • Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
  • Bratislava, Slovakia, 833 40
    • Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH
  • Kosice, Slovakia, 04001
    • Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
  • Kosice-Saca, Slovakia, 040 15
    • Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
  • Nitra, Slovakia, 949 01
    • Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
  • Svidnik, Slovakia, 089 01
    • SANARE spol. s.r.o., Dermatovenerologicka ambulancia
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28089
    • Hospital del Nino Jesus
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen De La Macarena
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro de Majadahonda
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University-Shuang Ho Hospital
  • Taichung City, Taiwan, R.O.C 402
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou Branch
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
    • Birmingham, Alabama, United States, 35244
      • Clinical Research Center of Alabama, LLC
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
  • California
    • Fountain Valley, California, United States, 92708
      • Tien Q Nguyen MD Inc dba First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Long Beach, California, United States, 90808
      • Beach Allergy and Asthma Specialty Group, A Medical Corporation
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
    • San Diego, California, United States, 92122
      • University of California San Diego
    • San Luis Obispo, California, United States, 93405
      • San Luis Dermatology and Laser Clinic
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc.
    • Santa Monica, California, United States, 90403
      • Mosaic Dermatology
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VAHCS
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Llc
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Tampa, Florida, United States, 33613
      • USF Asthma, Allergy & Immunology Clinical Research Unit
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists, PC
  • Illinois
    • Normal, Illinois, United States, 61761
      • Midwest Allergy Sinus Asthma, SC
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem Dermatology Clinical Trials Unit
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • Ds Research
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology, P.A.
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences Pllc
    • Louisville, Kentucky, United States, 40216
      • DXP Imaging
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research, LLC
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Dermatology Associates
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research, LLC
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Dermatology
  • 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
    • Rochester, New York, United States, 14620
      • UR Dermatology at College Town
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 - Wake Research, Inc.
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73120
      • Newton Clinical Research
  • 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
  • Texas
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment & Research Center, PA
    • Fort Worth, Texas, United States, 76244
      • Innovate Research, LLC
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center Houston
    • Hurst, Texas, United States, 76054
      • Ventavia Research Group Hurst
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates of Seattle
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 12 years of age or older with a minimum body weight of 40 kg
• Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)
• Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
• Prior treatment with JAK inhibitors
• Other active nonAD inflammatory skin diseases or conditions affecting skin
• 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
• 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-04965842 100 mg QD; Double-blind randomized treatment following open label run-in period.	Drug: PF-04965842 100 mg; PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks; Other Names: Abrocitinib
Experimental: PF-04965842 200 mg QD; Double-blind randomized treatment following open label run-in period.	Drug: PF-04965842 200 mg; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks; Other Names: Abrocitinib
Placebo Comparator: Placebo QD; Double-blind randomized treatment following open label run-in period.	Drug: Placebo; Placebo, administered as two tablets to be taken orally once daily for 40 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Loss of Response: Double-blind (DB) Period	Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe.	From Day 1 of up to Week 40 of double blind period
Time to Loss of Response: Double-blind Period	Time (in days) to loss of response based on achieving IGA >=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.	From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period	Time (in days) to loss of response based on achieving IGA >=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.	From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)
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 Weeks 12, 16, 28, 40, and 52: Double-blind Period	IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) was scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin] and lower limbs [l] [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); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.	Baseline, Weeks 12, 16, 28, 40 and 52
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity.	Baseline, Weeks 12, 16, 28, 40 and 52
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Baseline, Weeks 12, 16, 28, 40 and 52
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Baseline, Weeks 12, 16, 28, 40 and 52
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period	EASI quantifies severity of participant's 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) 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 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. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 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 added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using 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 added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome.	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.	Baseline, Weeks 12, 16, 28, 40 and 52
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	DLQI was a 10-item questionnaire that measures 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.	Baseline, Weeks 12, 16, 28, 40 and 52
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite 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 CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.	Baseline, Weeks 12, 16, 28, 40 and 52
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	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-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, 16, 28, 40 and 52
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	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-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, Weeks 12, 16, 28, 40 and 52
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	POEM was 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 scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity.	Baseline, Weeks 12, 16, 28, 40 and 52
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	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 [darker or lighter], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participants 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, Weeks 12, 16, 28, 40 and 52

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.
• 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.

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, 2018
• Primary Completion (Actual): September 2, 2020
• Study Completion (Actual): October 7, 2020

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

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: B7451014; JADE REGIMEN (Other Identifier: Alias Study Number); 2018-000501-23 (EudraCT Number); REGIMEN (Alias Study 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