Clinical trial NCT03627767: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Keywords: atopic dermatitis
atopic eczema
eczema
JAK
janus kinase
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 1235
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Loss of Response: Double-blind (DB) Period
timeFrame: From Day 1 of up to Week 40 of double blind period
measure: Time to Loss of Response: Double-blind Period
timeFrame: 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:
measure: Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period
timeFrame: 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)
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: 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
measure: Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period
timeFrame: 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
measure: 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
timeFrame: 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
measure: Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period
timeFrame: 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
measure: 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
timeFrame: 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
measure: Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
timeFrame: 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
measure: Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
timeFrame: 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
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: 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
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
measure: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
timeFrame: Baseline, Weeks 12, 16, 28, 40 and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Fountain Valley
country: United States
facility: Tien Q Nguyen MD Inc dba First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Long Beach
country: United States
facility: Beach Allergy and Asthma Specialty Group, A Medical Corporation
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology and Laser Clinic
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Santa Monica
country: United States
facility: Mosaic Dermatology
state: California
city: Bay Pines
country: United States
facility: Bay Pines VAHCS
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: USF Asthma, Allergy & Immunology Clinical Research Unit
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, PC
state: Georgia
city: Normal
country: United States
facility: Midwest Allergy Sinus Asthma, SC
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology Clinical Trials Unit
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Ds Research
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, P.A.
state: Kansas
city: Louisville
country: United States
facility: DXP Imaging
state: Kentucky
city: Louisville
country: United States
facility: Skin Sciences PLLC
state: Kentucky
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Juva Skin and Laser Center
state: New York
city: Rochester
country: United States
facility: UR Dermatology at College Town
state: New York
city: Raleigh
country: United States
facility: M3 - Wake Research, Inc.
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Newton Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc.
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center, PA
state: Texas
city: Fort Worth
country: United States
facility: Innovate Research, LLC
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center Houston
state: Texas
city: Hurst
country: United States
facility: Ventavia Research Group Hurst
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: La Plata
country: Argentina
facility: Framingham Centro Medico
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Rosario
country: Argentina
facility: Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC
state: Santa FE
city: C.a.b.a.
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas
city: C.a.b.a.
country: Argentina
facility: Buenos Aires Skin
city: C.a.b.a
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras LTDA.
state: PR
city: Rio de Janeiro
country: Brazil
facility: Instituto de Dermatologia e Estética do Brasil LTDA
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
state: RS
city: Santo Andre
country: Brazil
facility: Pesquisare Saude S/S Ltda
state: SP
city: Santo Andre
country: Brazil
facility: Fundacao do ABC - Faculdade de Medicina do ABC
state: SP
city: Rio de Janeiro
country: Brazil
facility: IBPClin Pesquisa Clinica
city: Dupnitsa
country: Bulgaria
facility: MC Asklepii" OOD
city: Gabrovo
country: Bulgaria
facility: MHAT "Dr. Tota Venkova" AD
city: Sofia
country: Bulgaria
facility: "Center of skin-venereal diseases" EOOD, Sofia
city: Sofia
country: Bulgaria
facility: "DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
city: Sofia
country: Bulgaria
facility: "Mc Sinexus Sofia" Eood
city: Sofia
country: Bulgaria
facility: ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
city: Varna
country: Bulgaria
facility: "ACIBADEM City Clinic Medical Center Varna" EOOD
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Dermasurgery Center
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: St. John's
country: Canada
facility: Karma Clinical Trials, Inc.
state: Newfoundland and Labrador
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Scarborough
country: Canada
facility: Office of Dr. Paul Adam
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research Inc.
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
city: Santiago
country: Chile
facility: Centro Medico SkinMed Limitada
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica Dermacross S.A.
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Región Metropolitana
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University, PLA
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong - Shenzhen Hospital
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital With Nanjing University
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital, Dermatological Department
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital/Dermatology Department
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie
city: Berlin
country: Germany
facility: Hautzentrum Friedrichshain Studien
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhoehe
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Halle
country: Germany
facility: Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Hamburg
country: Germany
facility: Katholisches Kinderkrankenhaus Wilhemstift
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Stuttgart
country: Germany
facility: Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: AOU Policlinico Sant'Orsola Malpighi
state: BO
city: Chieti
country: Italy
facility: Universita' degli Studi G. D'Annunzio -CeSi-MeT
state: CH
city: Roma
country: Italy
facility: IFO Istituto Dermatologico San Gallicano IRCCS,
state: RM
city: Roma
country: Italy
facility: Ospedale Cristo Re
state: Rome
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino di Genova
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Modena
country: Italy
facility: Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia
city: Rome
country: Italy
facility: Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
city: Riga
country: Latvia
facility: Riga 1st Hospital, Clinic of Dermatology and STD
city: Riga
country: Latvia
facility: Health and Aesthetics Ltd
city: Riga
country: Latvia
facility: Health Centre 4 Ltd, Dermatology Clinics
city: Ventspils
country: Latvia
facility: Outpatient Clinic Of Ventspils
city: Cuauhtemoc
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
state: Ciudad DE Mexico
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S. de R.L. de C.V.
state: Estado DE Mexico
city: Cuernavaca
country: Mexico
facility: JM Research SC
state: Morelos
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo LEON
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajio S.C
city: Chihuahua
country: Mexico
facility: Centro de Investigacion Integral Medivest S.C.
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum (UMC) Utrecht
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Chorzow
country: Poland
facility: Centrum Medyczne SENSEMED
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o., Oddzial w Katowicach
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. z o.o.
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne
city: Krakow
country: Poland
facility: Centrum Badan Klinicznych JCI
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
city: Lodz
country: Poland
facility: NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
city: Lodz
country: Poland
facility: O?rodek Bada? Klinicznych Appletreeclinics
city: Lodz
country: Poland
facility: Dermoklinika-Centrum Medyczne s.c.
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Szczecin
country: Poland
facility: Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
city: Warszawa
country: Poland
facility: RCMed Oddzial Warszawa
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. z o.o.
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny, Klinika Dermatologiczna
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Wroclaw
country: Poland
facility: Lukasz Matusiak "4Health'
city: Zabrze
country: Poland
facility: Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
city: Brasov
country: Romania
facility: SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
state: JUD. Brasov
city: Cluj-Napoca
country: Romania
facility: Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
state: Jud. Cluj
city: Bucuresti
country: Romania
facility: SC Delta Health Care SRL
city: Chelyabinsk
country: Russian Federation
facility: SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
city: Kemerovo
country: Russian Federation
facility: Limited Liability Company "Medical Center "Rheuma-Med"
city: Kirov
country: Russian Federation
facility: Clinic of FSBEI HE Kirov SMU MOH Russia
city: Moscow
country: Russian Federation
facility: FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
city: Moscow
country: Russian Federation
facility: NRC Institute of Immunology FMBA of Russia
city: Rostov-on-Don
country: Russian Federation
facility: SBI RR "Skin and Venereal Dispensary"
city: Ryazan
country: Russian Federation
facility: SBI RR "Regional Clinical Skin and Veneral Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: Medical Research Institute, LLC
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Pierre Wolkenstein Clinic of Skin Diseases"
city: Saint-Petersburg
country: Russian Federation
facility: Vitiligo center
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"
city: Saint-Petersburg
country: Russian Federation
facility: FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "Sanavita"
city: Saint-Petersburg
country: Russian Federation
facility: FSBEI HE I.P.Pavlov SPbSMU MOH Russia
city: Smolensk
country: Russian Federation
facility: RSBIH "Smolensk Regional Clinical Hospital"
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Nis
country: Serbia
facility: Clinical Centre Nis
city: Pancevo
country: Serbia
facility: General Hospital Pancevo
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica
city: Bratislava
country: Slovakia
facility: Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH
city: Bratislava
country: Slovakia
facility: BeneDerma s.r.o.
city: Bratislava
country: Slovakia
facility: Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
city: Kosice-Saca
country: Slovakia
facility: Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
city: Kosice
country: Slovakia
facility: Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
city: Nitra
country: Slovakia
facility: Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
city: Svidnik
country: Slovakia
facility: SANARE spol. s.r.o., Dermatovenerologicka ambulancia
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital del Nino Jesus
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.