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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,235

Participants

Timeline

Start Date

June 11, 2018

Primary Completion Date

September 2, 2020

Study Completion Date

October 7, 2020

Conditions
DermatitisDermatitis, AtopicEczemaSkin DiseasesSkin Diseases, GeneticGenetic Diseases, InbornSkin Diseases, EczematousHypersensitivityHypersensitivity, ImmediateImmune System Diseases
Interventions
DRUG

PF-04965842 100 mg

PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks

DRUG

PF-04965842 200 mg

PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks

DRUG

Placebo

Placebo, administered as two tablets to be taken orally once daily for 40 weeks

Trial Locations (235)

100

National Taiwan University Hospital, Taipei

333

Chang Gung Memorial Hospital Linkou Branch, Taoyuan

704

National Cheng-Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1090

University Hospital Brussels, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

1404

"Center of skin-venereal diseases EOOD, Sofia", Sofia

1463

"DCC Fokus-5-Medical Establishment for OutpatientCareEOOD", Sofia

1784

"Mc Sinexus Sofia Eood", Sofia

ACIBADEM City Clinic Diagnostic-Consultative Center EOOD, Sofia

2000

Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC, Rosario

2600

"MC Asklepii OOD", Dupnitsa

2650

University Hospital Antwerp, Edegem

5300

"MHAT Dr. Tota Venkova AD", Gabrovo

9000

"ACIBADEM City Clinic Medical Center Varna EOOD", Varna

10022

Juva Skin and Laser Center, New York

10117

Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie, Berlin

10247

Hautzentrum Friedrichshain Studien, Berlin

10783

Rothhaar Studien GmbH, Berlin

11000

Military Medical Academy, Belgrade

11374

Forest Hills Dermatology Group, Kew Gardens

14004

Hospital Universitario Reina Sofia, Córdoba

14620

UR Dermatology at College Town, Rochester

16132

Azienda Ospedaliero Universitaria San Martino di Genova, Genova

18000

Clinical Centre Nis, Niš

19103

Paddington Testing Co, Inc., Philadelphia

20127

Derma Norte del Bajio S.C, Aguascalientes

20157

Ospedale Luigi Sacco, Milan

20253

Klinische Forschung Hamburg GmbH, Hamburg

20537

TFS Trial Form Support GmbH, Hamburg

22149

Katholisches Kinderkrankenhaus Wilhemstift, Hamburg

22391

MENSINGDERMA research GmbH, Hamburg

23502

Virginia Clinical Research, Inc, Norfolk

23538

Universitaetsklinikum Schleswig-Holstein, Lübeck

23561

Taipei Medical University-Shuang Ho Hospital, New Taipei City

26000

General Hospital Pancevo, Pančevo

27612

M3 - Wake Research, Inc., Raleigh

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Universitario Gregorio Maranon, Madrid

28031

Hospital Universitario Infanta Leonor, Madrid

28046

Hospital Universitario La Paz, Madrid

28089

Hospital del Nino Jesus, Madrid

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda

30322

Emory University, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31203

Centro de Investigacion Integral Medivest S.C., Chihuahua City

31217

Dermatologic Surgery Specialists, PC, Macon

32073

Park Avenue Dermatology, Orange Park

33137

Baumann Cosmetic and Research Institute, Miami

33146

Skin Research Institute, Coral Gables

33486

Skin Care Research, LLC, Boca Raton

33613

USF Asthma, Allergy & Immunology Clinical Research Unit, Tampa

33647

Klinikum Bielefeld Rosenhoehe, Bielefeld

33744

Bay Pines VAHCS, Bay Pines

35205

Total Skin and Beauty Dermatology Center, PC, Birmingham

35233

University of Alabama at Birmingham, Dermatology at the Whitaker Clinic, Birmingham

35244

Clinical Research Center of Alabama, LLC, Birmingham

40138

AOU Policlinico Sant'Orsola Malpighi, Bologna

40216

DXP Imaging, Louisville

40217

Skin Sciences PLLC, Louisville

41009

Hospital Universitario Virgen de la Macarena, Seville

41124

Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia, Modena

42301

Qualmedica Research, LLC, Owensboro

42303

Owensboro Dermatology Associates, Owensboro

43209

Bexley Dermatology Research, Bexley

45147

Universitaetsklinikum Essen, Essen

46014

Consorcio Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitario y Politecnico La Fe, Valencia

46168

The Indiana Clinical Trials Center, Plainfield

46250

Dawes Fretzin Clinical Research Group, LLC, Indianapolis

47150

Ds Research, New Albany

53127

Universitaetsklinikum Bonn, Bonn

54769

Phylasis Clinicas Research S. de R.L. de C.V., Cuautitlán Izcalli

55905

Mayo Clinic, Rochester

57702

Health Concepts, Rapid City

60077

NorthShore University HealthSystem Dermatology Clinical Trials Unit, Skokie

61761

Midwest Allergy Sinus Asthma, SC, Normal

62290

JM Research SC, Cuernavaca

63104

Saint Louis University Dermatology, St Louis

64460

Centro de Dermatologia de Monterrey, Monterrey

64506

MediSearch Clinical Trials, Saint Joseph

66100

Universita' degli Studi G. D'Annunzio -CeSi-MeT, Chieti

66215

Kansas City Dermatology, P.A., Overland Park

70112

Tulane University Health Sciences Center, New Orleans

70178

Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen, Stuttgart

70808

Meridian Clinical Research, LLC, Baton Rouge

73112

Lynn Health Science Institute, Oklahoma City

73120

Newton Clinical Research, Oklahoma City

75230

Dermatology Treatment & Research Center, PA, Dallas

76054

Ventavia Research Group Hurst, Hurst

76244

Innovate Research, LLC, Fort Worth

77030

The University of Texas Health Science Center Houston, Houston

85101

Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia, Bratislava

89129

Praxis Dr. med. Beate Schwarz, Langenau

90403

Mosaic Dermatology, Santa Monica

90808

Beach Allergy and Asthma Specialty Group, A Medical Corporation, Long Beach

91054

Universitaetsklinikum Erlangen, Erlangen

92056

Dermatology Specialists, Inc., Oceanside

92122

University of California San Diego, San Diego

92701

Southern California Dermatology, Inc., Santa Ana

92708

Tien Q Nguyen MD Inc dba First OC Dermatology, Fountain Valley

93405

San Luis Dermatology and Laser Clinic, San Luis Obispo

94538

Center for Dermatology Clinical Research, Inc., Fremont

97223

Oregon Medical Research Center, Portland

98101

Dermatology Associates of Seattle, Seattle

99202

Dermatology Specialists of Spokane, Spokane

100034

Peking University First Hospital, Beijing

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

107076

"FSBI State Research Centre of Dermatovenereology and Cosmetology MoH RF", Moscow

115478

NRC Institute of Immunology FMBA of Russia, Moscow

191123

"LLC Pierre Wolkenstein Clinic of Skin Diseases", Saint Petersburg

Vitiligo center, Saint Petersburg

194021

"SPb SBIH Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology", Saint Petersburg

194100

"FSBEI HE St. Petersburg State Pediatric Medical University MoH RF", Saint Petersburg

195257

"Limited Liability Company Sanavita", Saint Petersburg

196084

Medical Research Institute, LLC, Saint Petersburg

197022

FSBEI HE I.P.Pavlov SPbSMU MOH Russia, Saint Petersburg

200003

Shanghai Changzheng Hospital, Shanghai

200040

Huashan Hospital Fudan University, Shanghai

200443

Shanghai Dermatology Hospital, Shanghai

210000

The First Affiliated Hospital With Nanjing University, Nanjing

214018

"RSBIH Smolensk Regional Clinical Hospital", Smolensk

250013

Jinan Central Hospital, Jinan

300052

Tianjin Medical University General Hospital, Dermatological Department, Tianjin

310003

The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept, Hangzhou

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept, Hangzhou

310014

Zhejiang Provincial People's Hospital/Dermatology Department, Hangzhou

310016

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou

330000

Dermatology Hospital of Jiangxi Province, Nanchang

344007

"SBI RR Skin and Venereal Dispensary", Rostov-on-Don

390046

"SBI RR Regional Clinical Skin and Veneral Dispensary", Ryazan

400037

The Second Affiliated Hospital of Army Medical University, PLA, Chongqing

400105

Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan, Cluj-Napoca

410011

The Second Xiangya Hospital of Central South University, Changsha

410013

The Third Xiangya Hospital of Central South University, Changsha

430030

Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan

454048

"SBIH Chelyabinsk Regional Clinical Dermatovenerology dispensary", Chelyabinsk

500283

SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL, Brasov

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

510630

The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou

518053

The University of Hong Kong - Shenzhen Hospital, Shenzhen

610014

Clinic of FSBEI HE Kirov SMU MOH Russia, Kirov

650070

"Limited Liability Company Medical Center Rheuma-Med", Kemerovo

3109601

Rambam Health Care Campus, Haifa

4941492

Rabin Medical Center, Petah Tikva

5265601

The Chaim Sheba Medical Center, Ramat Gan

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

7580206

Centro Medico SkinMed Limitada, Santiago

7640881

Clinica Dermacross S.A., Santiago

8380456

Hospital Clinico Universidad de Chile, Santiago

8410101

Soroka University Medical Center, Beersheba

8420383

Centro Internacional de Estudios Clinicos - CIEC, Santiago

02111

Tufts Medical Center, Boston

B1902COS

Framingham Centro Medico, La Plata

B1629ODT

Hospital Universitario Austral, Pilar

C1027AAP

CINME Centro de Investigaciones Metabolicas, C.a.b.a.

C1055AAO

Buenos Aires Skin, C.a.b.a.

C1425DKG

Psoriahue Medicina Interdisciplinaria, C.a.b.a

80030-110

CETI - Centro de Estudos em Terapias Inovadoras LTDA., Curitiba

22470-220

Instituto de Dermatologia e Estética do Brasil LTDA, Rio de Janeiro

90035-003

Hospital De Clinicas De Porto Alegre, Porto Alegre

90160-093

Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles, Porto Alegre

09.080-110

Pesquisare Saude S/S Ltda, Santo André

09060-870

Fundacao do ABC - Faculdade de Medicina do ABC, Santo André

20241-180

IBPClin Pesquisa Clinica, Rio de Janeiro

T1Y0B4

Dermatology Research Institute, Calgary

T5K 1X3

Stratica Medical, Edmonton

T6G1C3

Alberta Dermasurgery Center, Edmonton

R3M 3Z4

Wiseman Dermatology Research Inc., Winnipeg

A1A 4Y3

Karma Clinical Trials, Inc., St. John's

L1S 7K8

CCA Medical Research, Ajax

L4M 7G1

SimcoDerm Medical and Surgical Dermatology Center, Barrie

L3P 1X2

Lynderm Research Inc., Markham

L5H 1G9

DermEdge Research, Mississauga

K2C 3N2

Dermatology Ottawa Research Centre, Ottawa

K9J 5K2

SKiN Centre for Dermatology, Peterborough

M1B 4Z8

Office of Dr. Paul Adam, Scarborough Village

M5A 3R6

AvantDerm, Toronto

N2J 1C4

K. Papp Clinical Research, Waterloo

N8W 1E6

XLR8 Medical Research Inc., Windsor

G1V 4X7

Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ), Québec

01307

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden, Dresden

07548

SRH Wald-Klinikum Gera GmbH, Gera

06120

Universitätsklinikum und Poliklinik für Dermatologie und Venerologie, Halle

00144

IFO Istituto Dermatologico San Gallicano IRCCS,, Roma

00167

Ospedale Cristo Re, Roma

00168

Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia, Rome

LV - 1001

Riga 1st Hospital, Clinic of Dermatology and STD, Riga

LV-1009

Health and Aesthetics Ltd, Riga

LV-1013

Health Centre 4 Ltd, Dermatology Clinics, Riga

LV3601

Outpatient Clinic Of Ventspils, Ventspils

06700

Arke Estudios Clinicos S.A. de C.V., Cuauhtémoc

3584 CX

Universitair Medisch Centrum (UMC) Utrecht, Utrecht

85-065

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz

41-500

Centrum Medyczne SENSEMED, Chorzów

80-152

Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii, Gdansk

80-214

Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii, Gdansk

40-282

Silmedic Sp. z o.o., Oddzial w Katowicach, Katowice

40-611

Centrum Medyczne Angelius Provita, Katowice

40-648

Pro Familia Altera Sp. z o.o., Katowice

30-149

Malopolskie Centrum Kliniczne, Krakow

30-348

Centrum Badan Klinicznych JCI, Krakow

31-501

Krakowskie Centrum Medyczne Sp. z o.o., Krakow

90-242

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz

90-265

"NZOZ DERMED Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi", Lodz

90-349

O?rodek Bada? Klinicznych Appletreeclinics, Lodz

90-436

Dermoklinika-Centrum Medyczne s.c., Lodz

20-362

KO-MED Centra Kliniczne Lublin II, Lublin

27-400

Dermedic Jacek Zdybski, Ostrowiec Świętokrzyski

70-332

Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki, Szczecin

33-100

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o., Tarnów

01-192

Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warsaw

02-106

MTZ Clinical Research Sp. z o.o., Warsaw

02-507

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Warsaw

02-657

RCMed Oddzial Warszawa, Warsaw

02-758

Klinika Ambroziak Sp. z o.o., Warsaw

02-793

ETG Warszawa, Warsaw

04-141

Wojskowy Instytut Medyczny, Klinika Dermatologiczna, Warsaw

50-381

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw

50-566

"Lukasz Matusiak 4Health'", Wroclaw

41-800

Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii, Zabrze

014142

SC Delta Health Care SRL, Bucharest

975 17

Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica, Banská Bystrica

833 40

Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH, Bratislava

841 02

BeneDerma s.r.o., Bratislava

040 15

Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia, Kosice-Saca

04001

Pedi-Derma s.r.o., Dermatovenerologicka ambulancia, Košice

949 01

Derma-beauty, s.r.o., Dermatovenerologicka ambulancia, Nitra

089 01

SANARE spol. s.r.o., Dermatovenerologicka ambulancia, Svidník

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

03010

Hospital General Universitario de Alicante, Alicante

08036

Hospital Clinic de Barcelona, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

R.O.C 402

Chung Shan Medical University Hospital, Taichung

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03627767 - Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects | Biotech Hunter | Biotech Hunter