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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

Primary Purpose

Dermatitis, Dermatitis, Atopic, Eczema

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-04965842 100 mg
PF-04965842 200 mg
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis focused on measuring atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
  • Clinical Research Center of Alabama, LLC
  • Tien Q Nguyen MD Inc dba First OC Dermatology
  • Center for Dermatology Clinical Research, Inc.
  • Beach Allergy and Asthma Specialty Group, A Medical Corporation
  • Dermatology Specialists, Inc.
  • University of California San Diego
  • San Luis Dermatology and Laser Clinic
  • Southern California Dermatology, Inc.
  • Mosaic Dermatology
  • Bay Pines VAHCS
  • Skin Care Research, LLC
  • Skin Research Institute
  • Baumann Cosmetic and Research Institute
  • Park Avenue Dermatology
  • USF Asthma, Allergy & Immunology Clinical Research Unit
  • Emory University
  • Dermatologic Surgery Specialists, PC
  • Midwest Allergy Sinus Asthma, SC
  • NorthShore University HealthSystem Dermatology Clinical Trials Unit
  • Dawes Fretzin Clinical Research Group, LLC
  • Ds Research
  • The Indiana Clinical Trials Center
  • Kansas City Dermatology, P.A.
  • DXP Imaging
  • Skin Sciences PLLC
  • Qualmedica Research, LLC
  • Owensboro Dermatology Associates
  • Meridian Clinical Research, LLC
  • Tulane University Health Sciences Center
  • Tufts Medical Center
  • Mayo Clinic
  • MediSearch Clinical Trials
  • Saint Louis University Dermatology
  • Forest Hills Dermatology Group
  • Juva Skin and Laser Center
  • UR Dermatology at College Town
  • M3 - Wake Research, Inc.
  • Bexley Dermatology Research
  • Lynn Health Science Institute
  • Newton Clinical Research
  • Oregon Medical Research Center
  • Paddington Testing Co, Inc.
  • Health Concepts
  • Dermatology Treatment & Research Center, PA
  • Innovate Research, LLC
  • The University of Texas Health Science Center Houston
  • Ventavia Research Group Hurst
  • Virginia Clinical Research, Inc
  • Dermatology Associates of Seattle
  • Dermatology Specialists of Spokane
  • Framingham Centro Medico
  • Hospital Universitario Austral
  • Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC
  • CINME Centro de Investigaciones Metabolicas
  • Buenos Aires Skin
  • Psoriahue Medicina Interdisciplinaria
  • University Hospital Brussels
  • Cliniques Universitaires Saint-Luc
  • University Hospital Antwerp
  • CETI - Centro de Estudos em Terapias Inovadoras LTDA.
  • Instituto de Dermatologia e Estética do Brasil LTDA
  • Hospital De Clinicas De Porto Alegre
  • Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
  • Pesquisare Saude S/S Ltda
  • Fundacao do ABC - Faculdade de Medicina do ABC
  • IBPClin Pesquisa Clinica
  • MC Asklepii" OOD
  • MHAT "Dr. Tota Venkova" AD
  • "Center of skin-venereal diseases" EOOD, Sofia
  • "DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
  • "Mc Sinexus Sofia" Eood
  • ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
  • "ACIBADEM City Clinic Medical Center Varna" EOOD
  • Dermatology Research Institute
  • Stratica Medical
  • Alberta Dermasurgery Center
  • Wiseman Dermatology Research Inc.
  • Karma Clinical Trials, Inc.
  • CCA Medical Research
  • SimcoDerm Medical and Surgical Dermatology Center
  • Lynderm Research Inc.
  • DermEdge Research
  • Dermatology Ottawa Research Centre
  • SKiN Centre for Dermatology
  • Office of Dr. Paul Adam
  • AvantDerm
  • K. Papp Clinical Research
  • XLR8 Medical Research Inc.
  • Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
  • Centro Medico SkinMed Limitada
  • Clinica Dermacross S.A.
  • Centro Internacional de Estudios Clinicos - CIEC
  • Hospital Clinico Universidad de Chile
  • Beijing Friendship Hospital, Capital Medical University
  • The Second Affiliated Hospital of Army Medical University, PLA
  • The First Affiliated Hospital, Sun Yat-sen University
  • The Third Affiliated Hospital, Sun Yat-sen University
  • The University of Hong Kong - Shenzhen Hospital
  • Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
  • The Second Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South University
  • The First Affiliated Hospital With Nanjing University
  • Dermatology Hospital of Jiangxi Province
  • Jinan Central Hospital
  • Huashan Hospital Fudan University
  • Tianjin Medical University General Hospital, Dermatological Department
  • The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
  • The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
  • Zhejiang Provincial People's Hospital/Dermatology Department
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • Peking University First Hospital
  • Shanghai Changzheng Hospital
  • Shanghai Dermatology Hospital
  • Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie
  • Hautzentrum Friedrichshain Studien
  • Rothhaar Studien GmbH
  • Klinikum Bielefeld Rosenhoehe
  • Universitaetsklinikum Bonn
  • Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
  • Universitaetsklinikum Erlangen
  • Universitaetsklinikum Essen
  • SRH Wald-Klinikum Gera GmbH
  • Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
  • Klinische Forschung Hamburg GmbH
  • TFS Trial Form Support GmbH
  • Katholisches Kinderkrankenhaus Wilhemstift
  • MENSINGDERMA research GmbH
  • Medizinische Hochschule Hannover
  • Praxis Dr. med. Beate Schwarz
  • Universitaetsklinikum Schleswig-Holstein
  • Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
  • Soroka University Medical Center
  • Rambam Health Care Campus
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center
  • AOU Policlinico Sant'Orsola Malpighi
  • Universita' degli Studi G. D'Annunzio -CeSi-MeT
  • IFO Istituto Dermatologico San Gallicano IRCCS,
  • Ospedale Cristo Re
  • Azienda Ospedaliero Universitaria San Martino di Genova
  • Ospedale Luigi Sacco
  • Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia
  • Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
  • Riga 1st Hospital, Clinic of Dermatology and STD
  • Health and Aesthetics Ltd
  • Health Centre 4 Ltd, Dermatology Clinics
  • Outpatient Clinic Of Ventspils
  • Arke Estudios Clinicos S.A. de C.V.
  • Phylasis Clinicas Research S. de R.L. de C.V.
  • JM Research SC
  • Centro de Dermatologia de Monterrey
  • Derma Norte del Bajio S.C
  • Centro de Investigacion Integral Medivest S.C.
  • Universitair Medisch Centrum (UMC) Utrecht
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Centrum Medyczne SENSEMED
  • Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii
  • Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
  • Silmedic Sp. z o.o., Oddzial w Katowicach
  • Centrum Medyczne Angelius Provita
  • Pro Familia Altera Sp. z o.o.
  • Malopolskie Centrum Kliniczne
  • Centrum Badan Klinicznych JCI
  • Krakowskie Centrum Medyczne Sp. z o.o.
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
  • O?rodek Bada? Klinicznych Appletreeclinics
  • Dermoklinika-Centrum Medyczne s.c.
  • KO-MED Centra Kliniczne Lublin II
  • Dermedic Jacek Zdybski
  • Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • MTZ Clinical Research Sp. z o.o.
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
  • RCMed Oddzial Warszawa
  • Klinika Ambroziak Sp. z o.o.
  • ETG Warszawa
  • Wojskowy Instytut Medyczny, Klinika Dermatologiczna
  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • Lukasz Matusiak "4Health'
  • Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
  • SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
  • Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
  • SC Delta Health Care SRL
  • SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
  • Limited Liability Company "Medical Center "Rheuma-Med"
  • Clinic of FSBEI HE Kirov SMU MOH Russia
  • FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
  • NRC Institute of Immunology FMBA of Russia
  • SBI RR "Skin and Venereal Dispensary"
  • SBI RR "Regional Clinical Skin and Veneral Dispensary"
  • Medical Research Institute, LLC
  • LLC "Pierre Wolkenstein Clinic of Skin Diseases"
  • Vitiligo center
  • SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"
  • FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
  • Limited Liability Company "Sanavita"
  • FSBEI HE I.P.Pavlov SPbSMU MOH Russia
  • RSBIH "Smolensk Regional Clinical Hospital"
  • Military Medical Academy
  • Clinical Centre Nis
  • General Hospital Pancevo
  • Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica
  • Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH
  • BeneDerma s.r.o.
  • Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
  • Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
  • Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
  • Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
  • SANARE spol. s.r.o., Dermatovenerologicka ambulancia
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Sant Joan de Deu
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Hospital General Universitario de Alicante
  • Hospital Clinic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Reina Sofia
  • Hospital Universitario de La Princesa
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario La Paz
  • Hospital del Nino Jesus
  • Hospital Universitario Virgen de la Macarena
  • Consorcio Hospital General Universitario de Valencia
  • Hospital Universitario y Politecnico La Fe
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei Medical University-Shuang Ho Hospital
  • Chung Shan Medical University Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital Linkou Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PF-04965842 100 mg QD

PF-04965842 200 mg QD

Placebo QD

Arm Description

Double-blind randomized treatment following open label run-in period.

Double-blind randomized treatment following open label run-in period.

Double-blind randomized treatment following open label run-in period.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 29, 2018
Last Updated
September 17, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03627767
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04965842 100 mg QD
Arm Type
Experimental
Arm Description
Double-blind randomized treatment following open label run-in period.
Arm Title
PF-04965842 200 mg QD
Arm Type
Experimental
Arm Description
Double-blind randomized treatment following open label run-in period.
Arm Title
Placebo QD
Arm Type
Placebo Comparator
Arm Description
Double-blind randomized treatment following open label run-in period.
Intervention Type
Drug
Intervention Name(s)
PF-04965842 100 mg
Other Intervention Name(s)
Abrocitinib
Intervention Description
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04965842 200 mg
Other Intervention Name(s)
Abrocitinib
Intervention Description
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, administered as two tablets to be taken orally once daily for 40 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Loss of Response: Double-blind (DB) Period
Description
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.
Time Frame
From Day 1 of up to Week 40 of double blind period
Title
Time to Loss of Response: Double-blind Period
Description
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.
Time Frame
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 Measure Information:
Title
Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period
Description
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.
Time Frame
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)
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
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
Title
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period
Description
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.
Time Frame
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
Title
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
Description
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.
Time Frame
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
Title
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period
Description
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.
Time Frame
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
Title
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
Description
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.
Time Frame
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
Title
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
Description
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.
Time Frame
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
Title
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
Description
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.
Time Frame
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
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52
Title
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
Description
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.
Time Frame
Baseline, Weeks 12, 16, 28, 40 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Clinical Research Center of Alabama, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Tien Q Nguyen MD Inc dba First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Beach Allergy and Asthma Specialty Group, A Medical Corporation
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Dermatology Specialists, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
San Luis Dermatology and Laser Clinic
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Mosaic Dermatology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Bay Pines VAHCS
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Skin Care Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Skin Research Institute
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Baumann Cosmetic and Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
USF Asthma, Allergy & Immunology Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dermatologic Surgery Specialists, PC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Midwest Allergy Sinus Asthma, SC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
NorthShore University HealthSystem Dermatology Clinical Trials Unit
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Ds Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Kansas City Dermatology, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
DXP Imaging
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40216
Country
United States
Facility Name
Skin Sciences PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Qualmedica Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Owensboro Dermatology Associates
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11374
Country
United States
Facility Name
Juva Skin and Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
UR Dermatology at College Town
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
M3 - Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Newton Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Paddington Testing Co, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Dermatology Treatment & Research Center, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Innovate Research, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244
Country
United States
Facility Name
The University of Texas Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ventavia Research Group Hurst
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Associates of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Dermatology Specialists of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Framingham Centro Medico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
CINME Centro de Investigaciones Metabolicas
City
C.a.b.a.
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Buenos Aires Skin
City
C.a.b.a.
ZIP/Postal Code
C1055AAO
Country
Argentina
Facility Name
Psoriahue Medicina Interdisciplinaria
City
C.a.b.a
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras LTDA.
City
Curitiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Instituto de Dermatologia e Estética do Brasil LTDA
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22470-220
Country
Brazil
Facility Name
Hospital De Clinicas De Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160-093
Country
Brazil
Facility Name
Pesquisare Saude S/S Ltda
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09.080-110
Country
Brazil
Facility Name
Fundacao do ABC - Faculdade de Medicina do ABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
IBPClin Pesquisa Clinica
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
MC Asklepii" OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
MHAT "Dr. Tota Venkova" AD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
"Center of skin-venereal diseases" EOOD, Sofia
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
"DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
"Mc Sinexus Sofia" Eood
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
"ACIBADEM City Clinic Medical Center Varna" EOOD
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y0B4
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Alberta Dermasurgery Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1C3
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Karma Clinical Trials, Inc.
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Dermatology Ottawa Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Office of Dr. Paul Adam
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
AvantDerm
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5A 3R6
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
XLR8 Medical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Centro Medico SkinMed Limitada
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7580206
Country
Chile
Facility Name
Clinica Dermacross S.A.
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Centro Internacional de Estudios Clinicos - CIEC
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
The Second Affiliated Hospital of Army Medical University, PLA
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Third Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
The University of Hong Kong - Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518053
Country
China
Facility Name
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First Affiliated Hospital With Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Dermatology Hospital of Jiangxi Province
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Tianjin Medical University General Hospital, Dermatological Department
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Provincial People's Hospital/Dermatology Department
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
ZIP/Postal Code
200443
Country
China
Facility Name
Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Hautzentrum Friedrichshain Studien
City
Berlin
ZIP/Postal Code
10247
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Klinikum Bielefeld Rosenhoehe
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Katholisches Kinderkrankenhaus Wilhemstift
City
Hamburg
ZIP/Postal Code
22149
Country
Germany
Facility Name
MENSINGDERMA research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Praxis Dr. med. Beate Schwarz
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
AOU Policlinico Sant'Orsola Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Universita' degli Studi G. D'Annunzio -CeSi-MeT
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy
Facility Name
IFO Istituto Dermatologico San Gallicano IRCCS,
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Facility Name
Ospedale Cristo Re
City
Roma
State/Province
Rome
ZIP/Postal Code
00167
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Riga 1st Hospital, Clinic of Dermatology and STD
City
Riga
ZIP/Postal Code
LV - 1001
Country
Latvia
Facility Name
Health and Aesthetics Ltd
City
Riga
ZIP/Postal Code
LV-1009
Country
Latvia
Facility Name
Health Centre 4 Ltd, Dermatology Clinics
City
Riga
ZIP/Postal Code
LV-1013
Country
Latvia
Facility Name
Outpatient Clinic Of Ventspils
City
Ventspils
ZIP/Postal Code
LV3601
Country
Latvia
Facility Name
Arke Estudios Clinicos S.A. de C.V.
City
Cuauhtemoc
State/Province
Ciudad DE Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Phylasis Clinicas Research S. de R.L. de C.V.
City
Cuautitlan Izcalli
State/Province
Estado DE Mexico
ZIP/Postal Code
54769
Country
Mexico
Facility Name
JM Research SC
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Centro de Dermatologia de Monterrey
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Derma Norte del Bajio S.C
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Centro de Investigacion Integral Medivest S.C.
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Universitair Medisch Centrum (UMC) Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Centrum Medyczne SENSEMED
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii
City
Gdansk
ZIP/Postal Code
80-152
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Silmedic Sp. z o.o., Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Pro Familia Altera Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne
City
Krakow
ZIP/Postal Code
30-149
Country
Poland
Facility Name
Centrum Badan Klinicznych JCI
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
O?rodek Bada? Klinicznych Appletreeclinics
City
Lodz
ZIP/Postal Code
90-349
Country
Poland
Facility Name
Dermoklinika-Centrum Medyczne s.c.
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Dermedic Jacek Zdybski
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
RCMed Oddzial Warszawa
City
Warszawa
ZIP/Postal Code
02-657
Country
Poland
Facility Name
Klinika Ambroziak Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Lukasz Matusiak "4Health'
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
City
Brasov
State/Province
JUD. Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
City
Cluj-Napoca
State/Province
Jud. Cluj
ZIP/Postal Code
400105
Country
Romania
Facility Name
SC Delta Health Care SRL
City
Bucuresti
ZIP/Postal Code
014142
Country
Romania
Facility Name
SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Limited Liability Company "Medical Center "Rheuma-Med"
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Facility Name
Clinic of FSBEI HE Kirov SMU MOH Russia
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
NRC Institute of Immunology FMBA of Russia
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
SBI RR "Skin and Venereal Dispensary"
City
Rostov-on-Don
ZIP/Postal Code
344007
Country
Russian Federation
Facility Name
SBI RR "Regional Clinical Skin and Veneral Dispensary"
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Medical Research Institute, LLC
City
Saint Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
LLC "Pierre Wolkenstein Clinic of Skin Diseases"
City
Saint-Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
Vitiligo center
City
Saint-Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology"
City
Saint-Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
City
Saint-Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Limited Liability Company "Sanavita"
City
Saint-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
FSBEI HE I.P.Pavlov SPbSMU MOH Russia
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
RSBIH "Smolensk Regional Clinical Hospital"
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
General Hospital Pancevo
City
Pancevo
ZIP/Postal Code
26000
Country
Serbia
Facility Name
Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
BeneDerma s.r.o.
City
Bratislava
ZIP/Postal Code
841 02
Country
Slovakia
Facility Name
Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
City
Kosice-Saca
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
SANARE spol. s.r.o., Dermatovenerologicka ambulancia
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital del Nino Jesus
City
Madrid
ZIP/Postal Code
28089
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taipei Medical University-Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
R.O.C 402
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35342978
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.
Results Reference
derived
PubMed Identifier
34406619
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. Erratum In: Am J Clin Dermatol. 2021 Nov;22(6):905.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7451014
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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