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
4 other identifiers
interventional
1,235
21 countries
235
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedStudy Start
First participant enrolled
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2020
CompletedResults Posted
Study results publicly available
September 20, 2021
CompletedSeptember 20, 2021
September 1, 2021
2.2 years
May 29, 2018
August 3, 2021
September 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (26)
Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period
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
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
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
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
Baseline, Weeks 12, 16, 28, 40 and 52
- +21 more secondary outcomes
Study Arms (3)
PF-04965842 100 mg QD
EXPERIMENTALDouble-blind randomized treatment following open label run-in period.
PF-04965842 200 mg QD
EXPERIMENTALDouble-blind randomized treatment following open label run-in period.
Placebo QD
PLACEBO COMPARATORDouble-blind randomized treatment following open label run-in period.
Interventions
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
Placebo, administered as two tablets to be taken orally once daily for 40 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (235)
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Birmingham, Alabama, 35233, United States
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35244, United States
Tien Q Nguyen MD Inc dba First OC Dermatology
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach, California, 90808, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
University of California San Diego
San Diego, California, 92122, United States
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, 93405, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Mosaic Dermatology
Santa Monica, California, 90403, United States
Bay Pines VAHCS
Bay Pines, Florida, 33744, United States
Skin Care Research, LLC
Boca Raton, Florida, 33486, United States
Skin Research Institute
Coral Gables, Florida, 33146, United States
Baumann Cosmetic and Research Institute
Miami, Florida, 33137, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
USF Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, 33613, United States
Emory University
Atlanta, Georgia, 30322, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217, United States
Midwest Allergy Sinus Asthma, SC
Normal, Illinois, 61761, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, 60077, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Ds Research
New Albany, Indiana, 47150, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Kansas City Dermatology, P.A.
Overland Park, Kansas, 66215, United States
DXP Imaging
Louisville, Kentucky, 40216, United States
Skin Sciences PLLC
Louisville, Kentucky, 40217, United States
Qualmedica Research, LLC
Owensboro, Kentucky, 42301, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Saint Louis University Dermatology
St Louis, Missouri, 63104, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11374, United States
Juva Skin and Laser Center
New York, New York, 10022, United States
UR Dermatology at College Town
Rochester, New York, 14620, United States
M3 - Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Newton Clinical Research
Oklahoma City, Oklahoma, 73120, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 19103, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Dermatology Treatment & Research Center, PA
Dallas, Texas, 75230, United States
Innovate Research, LLC
Fort Worth, Texas, 76244, United States
The University of Texas Health Science Center Houston
Houston, Texas, 77030, United States
Ventavia Research Group Hurst
Hurst, Texas, 76054, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23502, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101, United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202, United States
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC
Rosario, Santa Fe Province, 2000, Argentina
CINME Centro de Investigaciones Metabolicas
C.a.b.a., C1027AAP, Argentina
Buenos Aires Skin
C.a.b.a., C1055AAO, Argentina
Psoriahue Medicina Interdisciplinaria
C.a.b.a, C1425DKG, Argentina
University Hospital Brussels
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
CETI - Centro de Estudos em Terapias Inovadoras LTDA.
Curitiba, Paraná, 80030-110, Brazil
Instituto de Dermatologia e Estética do Brasil LTDA
Rio de Janeiro, Rio de Janeiro, 22470-220, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Pesquisare Saude S/S Ltda
Santo André, São Paulo, 09.080-110, Brazil
Fundacao do ABC - Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
IBPClin Pesquisa Clinica
Rio de Janeiro, 20241-180, Brazil
MC Asklepii" OOD
Dupnitsa, 2600, Bulgaria
MHAT "Dr. Tota Venkova" AD
Gabrovo, 5300, Bulgaria
"Center of skin-venereal diseases" EOOD, Sofia
Sofia, 1404, Bulgaria
"DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
Sofia, 1463, Bulgaria
"Mc Sinexus Sofia" Eood
Sofia, 1784, Bulgaria
ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
Sofia, 1784, Bulgaria
"ACIBADEM City Clinic Medical Center Varna" EOOD
Varna, 9000, Bulgaria
Dermatology Research Institute
Calgary, Alberta, T1Y0B4, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Alberta Dermasurgery Center
Edmonton, Alberta, T6G1C3, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Karma Clinical Trials, Inc.
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
DermEdge Research
Mississauga, Ontario, L5H 1G9, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Office of Dr. Paul Adam
Scarborough Village, Ontario, M1B 4Z8, Canada
AvantDerm
Toronto, Ontario, M5A 3R6, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
Québec, Quebec, G1V 4X7, Canada
Centro Medico SkinMed Limitada
Santiago, Santiago Metropolitan, 7580206, Chile
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881, Chile
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Santiago Metropolitan, 8420383, Chile
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The Second Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, 400037, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital With Nanjing University
Nanjing, Jiangsu, 210000, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
Hangzhou, Zhejiang, 310009, China
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, 310014, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Peking University First Hospital
Beijing, 100034, China
Shanghai Changzheng Hospital
Shanghai, 200003, China
Shanghai Dermatology Hospital
Shanghai, 200443, China
Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie
Berlin, 10117, Germany
Hautzentrum Friedrichshain Studien
Berlin, 10247, Germany
Rothhaar Studien GmbH
Berlin, 10783, Germany
Klinikum Bielefeld Rosenhoehe
Bielefeld, 33647, Germany
Universitaetsklinikum Bonn
Bonn, 53127, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, 01307, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
Halle, 06120, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
TFS Trial Form Support GmbH
Hamburg, 20537, Germany
Katholisches Kinderkrankenhaus Wilhemstift
Hamburg, 22149, Germany
MENSINGDERMA research GmbH
Hamburg, 22391, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Praxis Dr. med. Beate Schwarz
Langenau, 89129, Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
Stuttgart, 70178, Germany
Soroka University Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138, Italy
Universita' degli Studi G. D'Annunzio -CeSi-MeT
Chieti, CH, 66100, Italy
IFO Istituto Dermatologico San Gallicano IRCCS,
Roma, RM, 00144, Italy
Ospedale Cristo Re
Roma, ROME, 00167, Italy
Azienda Ospedaliero Universitaria San Martino di Genova
Genova, 16132, Italy
Ospedale Luigi Sacco
Milan, 20157, Italy
Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia
Modena, 41124, Italy
Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
Rome, 00168, Italy
Riga 1st Hospital, Clinic of Dermatology and STD
Riga, LV - 1001, Latvia
Health and Aesthetics Ltd
Riga, LV-1009, Latvia
Health Centre 4 Ltd, Dermatology Clinics
Riga, LV-1013, Latvia
Outpatient Clinic Of Ventspils
Ventspils, LV3601, Latvia
Arke Estudios Clinicos S.A. de C.V.
Cuauhtémoc, Mexico City, 06700, Mexico
JM Research SC
Cuernavaca, Morelos, 62290, Mexico
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, 64460, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, State of Mexico, 54769, Mexico
Derma Norte del Bajio S.C
Aguascalientes, 20127, Mexico
Centro de Investigacion Integral Medivest S.C.
Chihuahua City, 31203, Mexico
Universitair Medisch Centrum (UMC) Utrecht
Utrecht, 3584 CX, Netherlands
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-065, Poland
Centrum Medyczne SENSEMED
Chorzów, 41-500, Poland
Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii
Gdansk, 80-152, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
Gdansk, 80-214, Poland
Silmedic Sp. z o.o., Oddzial w Katowicach
Katowice, 40-282, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Pro Familia Altera Sp. z o.o.
Katowice, 40-648, Poland
Malopolskie Centrum Kliniczne
Krakow, 30-149, Poland
Centrum Badan Klinicznych JCI
Krakow, 30-348, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-242, Poland
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
Lodz, 90-265, Poland
O?rodek Bada? Klinicznych Appletreeclinics
Lodz, 90-349, Poland
Dermoklinika-Centrum Medyczne s.c.
Lodz, 90-436, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki
Szczecin, 70-332, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, 33-100, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warsaw, 02-507, Poland
RCMed Oddzial Warszawa
Warsaw, 02-657, Poland
Klinika Ambroziak Sp. z o.o.
Warsaw, 02-758, Poland
ETG Warszawa
Warsaw, 02-793, Poland
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
Warsaw, 04-141, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-381, Poland
Lukasz Matusiak "4Health'
Wroclaw, 50-566, Poland
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
Zabrze, 41-800, Poland
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, JUD. Brasov, 500283, Romania
Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
Cluj-Napoca, JUD. CLUJ, 400105, Romania
SC Delta Health Care SRL
Bucharest, 014142, Romania
SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
Chelyabinsk, 454048, Russia
Limited Liability Company "Medical Center "Rheuma-Med"
Kemerovo, 650070, Russia
Clinic of FSBEI HE Kirov SMU MOH Russia
Kirov, 610014, Russia
FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
Moscow, 107076, Russia
NRC Institute of Immunology FMBA of Russia
Moscow, 115478, Russia
SBI RR "Skin and Venereal Dispensary"
Rostov-on-Don, 344007, Russia
SBI RR "Regional Clinical Skin and Veneral Dispensary"
Ryazan, 390046, Russia
LLC "Pierre Wolkenstein Clinic of Skin Diseases"
Saint Petersburg, 191123, Russia
Vitiligo center
Saint Petersburg, 191123, Russia
SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"
Saint Petersburg, 194021, Russia
FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
Saint Petersburg, 194100, Russia
Limited Liability Company "Sanavita"
Saint Petersburg, 195257, Russia
Medical Research Institute, LLC
Saint Petersburg, 196084, Russia
FSBEI HE I.P.Pavlov SPbSMU MOH Russia
Saint Petersburg, 197022, Russia
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, 214018, Russia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Centre Nis
Niš, 18000, Serbia
General Hospital Pancevo
Pančevo, 26000, Serbia
Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH
Bratislava, 833 40, Slovakia
BeneDerma s.r.o.
Bratislava, 841 02, Slovakia
Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
Bratislava, 85101, Slovakia
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
Kosice-Saca, 040 15, Slovakia
Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
Košice, 04001, Slovakia
Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
Nitra, 949 01, Slovakia
SANARE spol. s.r.o., Dermatovenerologicka ambulancia
Svidník, 089 01, Slovakia
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital del Nino Jesus
Madrid, 28089, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, R.O.C 402, Taiwan
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333, Taiwan
Related Publications (5)
Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.
PMID: 40028832DERIVEDArmstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
PMID: 38896380DERIVEDFlohr C, Cork MJ, Ardern-Jones MR, Eichenfield LF, Barbarot S, Feeney C, Rojo R, Lazariciu I, Nesnas J. Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial. J Dermatolog Treat. 2023 Dec;34(1):2200866. doi: 10.1080/09546634.2023.2200866.
PMID: 37036183DERIVEDWojciechowski 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.
PMID: 35342978DERIVEDSimpson 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.
PMID: 34406619DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
For outcome measure, Time to loss of response, the data collection window was extended for 45 days beyond the scheduled visit due to COVID 19.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2018
First Posted
August 13, 2018
Study Start
June 11, 2018
Primary Completion
September 2, 2020
Study Completion
October 7, 2020
Last Updated
September 20, 2021
Results First Posted
September 20, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
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.