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
NCT ID: NCT03627767
Last Updated: 2021-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1235 participants
INTERVENTIONAL
2018-06-11
2020-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-04965842 100 mg QD
Double-blind randomized treatment following open label run-in period.
PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
PF-04965842 200 mg QD
Double-blind randomized treatment following open label run-in period.
PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
Placebo QD
Double-blind randomized treatment following open label run-in period.
Placebo
Placebo, administered as two tablets to be taken orally once daily for 40 weeks
Interventions
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PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
Placebo
Placebo, administered as two tablets to be taken orally once daily for 40 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Birmingham, Alabama, United States
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Tien Q Nguyen MD Inc dba First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach, California, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
University of California San Diego
San Diego, California, United States
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
Mosaic Dermatology
Santa Monica, California, United States
Bay Pines VAHCS
Bay Pines, Florida, United States
Skin Care Research, LLC
Boca Raton, Florida, United States
Skin Research Institute
Coral Gables, Florida, United States
Baumann Cosmetic and Research Institute
Miami, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
USF Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States
Midwest Allergy Sinus Asthma, SC
Normal, Illinois, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Ds Research
New Albany, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Kansas City Dermatology, P.A.
Overland Park, Kansas, United States
DXP Imaging
Louisville, Kentucky, United States
Skin Sciences PLLC
Louisville, Kentucky, United States
Qualmedica Research, LLC
Owensboro, Kentucky, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Juva Skin and Laser Center
New York, New York, United States
UR Dermatology at College Town
Rochester, New York, United States
M3 - Wake Research, Inc.
Raleigh, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Newton Clinical Research
Oklahoma City, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States
Innovate Research, LLC
Fort Worth, Texas, United States
The University of Texas Health Science Center Houston
Houston, Texas, United States
Ventavia Research Group Hurst
Hurst, Texas, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Dermatology Associates of Seattle
Seattle, Washington, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Framingham Centro Medico
La Plata, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC
Rosario, Santa Fe Province, Argentina
CINME Centro de Investigaciones Metabolicas
C.a.b.a., , Argentina
Buenos Aires Skin
C.a.b.a., , Argentina
Psoriahue Medicina Interdisciplinaria
C.a.b.a, , Argentina
University Hospital Brussels
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
CETI - Centro de Estudos em Terapias Inovadoras LTDA.
Curitiba, Paraná, Brazil
Instituto de Dermatologia e Estética do Brasil LTDA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Pesquisare Saude S/S Ltda
Santo André, São Paulo, Brazil
Fundacao do ABC - Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
IBPClin Pesquisa Clinica
Rio de Janeiro, , Brazil
MC Asklepii" OOD
Dupnitsa, , Bulgaria
MHAT "Dr. Tota Venkova" AD
Gabrovo, , Bulgaria
"Center of skin-venereal diseases" EOOD, Sofia
Sofia, , Bulgaria
"DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
Sofia, , Bulgaria
"Mc Sinexus Sofia" Eood
Sofia, , Bulgaria
ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
Sofia, , Bulgaria
"ACIBADEM City Clinic Medical Center Varna" EOOD
Varna, , Bulgaria
Dermatology Research Institute
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Alberta Dermasurgery Center
Edmonton, Alberta, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Karma Clinical Trials, Inc.
St. John's, Newfoundland and Labrador, Canada
CCA Medical Research
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Office of Dr. Paul Adam
Scarborough Village, Ontario, Canada
AvantDerm
Toronto, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
Québec, Quebec, Canada
Centro Medico SkinMed Limitada
Santiago, Santiago Metropolitan, Chile
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, Chile
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Santiago Metropolitan, Chile
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital With Nanjing University
Nanjing, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Jinan Central Hospital
Jinan, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, , China
Shanghai Changzheng Hospital
Shanghai, , China
Shanghai Dermatology Hospital
Shanghai, , China
Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie
Berlin, , Germany
Hautzentrum Friedrichshain Studien
Berlin, , Germany
Rothhaar Studien GmbH
Berlin, , Germany
Klinikum Bielefeld Rosenhoehe
Bielefeld, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
SRH Wald-Klinikum Gera GmbH
Gera, , Germany
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
Halle, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Katholisches Kinderkrankenhaus Wilhemstift
Hamburg, , Germany
MENSINGDERMA research GmbH
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Praxis Dr. med. Beate Schwarz
Langenau, , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, , Germany
Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
Stuttgart, , Germany
Soroka University Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, Italy
Universita' degli Studi G. D'Annunzio -CeSi-MeT
Chieti, CH, Italy
IFO Istituto Dermatologico San Gallicano IRCCS,
Roma, RM, Italy
Ospedale Cristo Re
Roma, ROME, Italy
Azienda Ospedaliero Universitaria San Martino di Genova
Genova, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia
Modena, , Italy
Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
Rome, , Italy
Riga 1st Hospital, Clinic of Dermatology and STD
Riga, , Latvia
Health and Aesthetics Ltd
Riga, , Latvia
Health Centre 4 Ltd, Dermatology Clinics
Riga, , Latvia
Outpatient Clinic Of Ventspils
Ventspils, , Latvia
Arke Estudios Clinicos S.A. de C.V.
Cuauhtémoc, Mexico City, Mexico
JM Research SC
Cuernavaca, Morelos, Mexico
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, State of Mexico, Mexico
Derma Norte del Bajio S.C
Aguascalientes, , Mexico
Centro de Investigacion Integral Medivest S.C.
Chihuahua City, , Mexico
Universitair Medisch Centrum (UMC) Utrecht
Utrecht, , Netherlands
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Centrum Medyczne SENSEMED
Chorzów, , Poland
Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
Gdansk, , Poland
Silmedic Sp. z o.o., Oddzial w Katowicach
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Pro Familia Altera Sp. z o.o.
Katowice, , Poland
Malopolskie Centrum Kliniczne
Krakow, , Poland
Centrum Badan Klinicznych JCI
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
Lodz, , Poland
O?rodek Bada? Klinicznych Appletreeclinics
Lodz, , Poland
Dermoklinika-Centrum Medyczne s.c.
Lodz, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki
Szczecin, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warsaw, , Poland
RCMed Oddzial Warszawa
Warsaw, , Poland
Klinika Ambroziak Sp. z o.o.
Warsaw, , Poland
ETG Warszawa
Warsaw, , Poland
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, , Poland
Lukasz Matusiak "4Health'
Wroclaw, , Poland
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
Zabrze, , Poland
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, JUD. Brasov, Romania
Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
Cluj-Napoca, JUD. CLUJ, Romania
SC Delta Health Care SRL
Bucharest, , Romania
SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
Chelyabinsk, , Russia
Limited Liability Company "Medical Center "Rheuma-Med"
Kemerovo, , Russia
Clinic of FSBEI HE Kirov SMU MOH Russia
Kirov, , Russia
FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
Moscow, , Russia
NRC Institute of Immunology FMBA of Russia
Moscow, , Russia
SBI RR "Skin and Venereal Dispensary"
Rostov-on-Don, , Russia
SBI RR "Regional Clinical Skin and Veneral Dispensary"
Ryazan, , Russia
LLC "Pierre Wolkenstein Clinic of Skin Diseases"
Saint Petersburg, , Russia
Vitiligo center
Saint Petersburg, , Russia
SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"
Saint Petersburg, , Russia
FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
Saint Petersburg, , Russia
Limited Liability Company "Sanavita"
Saint Petersburg, , Russia
Medical Research Institute, LLC
Saint Petersburg, , Russia
FSBEI HE I.P.Pavlov SPbSMU MOH Russia
Saint Petersburg, , Russia
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, , Russia
Military Medical Academy
Belgrade, , Serbia
Clinical Centre Nis
Niš, , Serbia
General Hospital Pancevo
Pančevo, , Serbia
Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica
Banská Bystrica, , Slovakia
Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH
Bratislava, , Slovakia
BeneDerma s.r.o.
Bratislava, , Slovakia
Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
Bratislava, , Slovakia
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
Kosice-Saca, , Slovakia
Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
Košice, , Slovakia
Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
Nitra, , Slovakia
SANARE spol. s.r.o., Dermatovenerologicka ambulancia
Svidník, , Slovakia
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital del Nino Jesus
Madrid, , Spain
Hospital Universitario Virgen de la Macarena
Seville, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Cheng-Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, , Taiwan
Countries
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References
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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.
Armstrong 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.
Flohr 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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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JADE REGIMEN
Identifier Type: OTHER
Identifier Source: secondary_id
2018-000501-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REGIMEN
Identifier Type: OTHER
Identifier Source: secondary_id
B7451014
Identifier Type: -
Identifier Source: org_study_id
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