838
Participants
Start Date
October 29, 2018
Primary Completion Date
December 27, 2019
Study Completion Date
March 6, 2020
PF-04965842 100 mg
"PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows:~1. In the arm PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg, PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;~2. In the arm Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 subjects take PF-04965842 100 mg from Week 16 to Week 20."
PF-04965842 200 mg
"PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows:~1. In the arm PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg, PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;~2. In the arm Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842 subjects take PF-04965842 200 mg from Week 16 to Week 20."
Dupilumab
Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.
Oral Placebo
"Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows:~1. In the arm Dupilumab Injection + Oral Placebo followed by Oral Placebo, the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;~2. In the arms Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 and Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842, subjects, take Oral Placebo from Day 1 until Week 16."
Injectable Placebo
Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
National Taiwan University Hospital, Taipei
National Cheng-Kung University Hospital, Tainan City
DCC 2/Sofia EOOD, Sofia
SE AOK Bor-, Nemikortani es Boronkologiai Klinika, Budapest
"DCC Aleksandrovska EOOD", Sofia
"Dermatology Clinic Sofia Ltd", Sofia
"Mc Synexus Sofia Eood", Sofia
Australian Clinical Research Network, Maroubra
Woden Dermatology, Phillip
Sinclair Dermatology, East Melbourne
Royal Melbourne Hospital, Parkville
Skin and Cancer Foundation Inc, Carlton
Emeritus Research, Camberwell
Box Hill Hospital, Box Hill
Debreceni Egyetem Klinikai Kozpont, Debrecen
Veracity Clinical Research Pty Ltd, Woolloongabba
Trial Pharma Kft., Püspökladány
The Skin Centre, Benowa
North Eastern Health Specialists, Hectorville
Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS, Gyula
Medical Centre Synexus Sofia EOOD-branch Stara Zagora, Stara Zagora
Medmare Bt, Veszprém
"DCC Mladost-M Varna OOD", Varna
Juva Skin and Laser Center, New York
Mackay Memorial Hospital, Taipei
Sanatorium profesora Arenbergera, Prague
Taipei Veterans General Hospital, Taipei
Forest Hills Dermatology Group, Kew Gardens
TrialSpark, Inc (Russell Cohen), Oceanside
Soon Chun Hyang University Bucheon Hospital, Bucheon-si
Korea University Ansan Hospital, Ansan-si
Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling, Mahlow
Paddington Testing Co, Inc., Philadelphia
The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon
Virginia Dermatology and Skin Cancer Center, Norfolk
Velocity Urgent Care, Norfolk
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck, Lübeck
Universitaetsklinikum Schleswig-Holstein, Campus Kiel, Kiel
Winston-Salem Dermatology and Surgery Center, PLLC, Winston-Salem
Medication Management, LLC, Greensboro
Cary Dermatology Center, PA, Cary
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare, Statesville
Hospital Universitario Fundacion Alcorcon, Alcorcón
Synexus Clinical Research US, Inc., Anderson
Synexus Clinical Research US. Inc., Greer
Columbus Regional Research Institute, Columbus
Solutions Through Advanced Research, Inc., Jacksonville
Wellness Clinical Research, LLC, Miami Lakes
Savin Medical Group LLC, Miami
C & R Research Services USA, Inc, Coral Gables
Florida Academic Centers Research and Education, LLC, Coral Gables
Moonshine Research Center, Inc., Doral
Research Institute of Southeast, LLC, West Palm Beach
Research Institute of the Southeast, LLC, West Palm Beach
ForCare Clinical Research, Tampa
Klinikum Bielefeld Rosenhohe, Bielefeld
Olympian Clinical Research, Largo
Renaissance Research and Medical Group, Inc, Cape Coral
Chungnam National University Hospital CNUH, Daejeon
Universitätsklinikum Marburg, Marburg
Clinical Research Center of Alabama, LLC, Birmingham
The University Of Alabama At Birmingham, Birmingham
Chung Shan Medical University Hospital (CSMUH), Taichung
Forefront Dermatology, S.C., Louisville
Taichung Veterans General Hospital, Taichung
AOU Policlinico di Modena, Struttura Complessa di Dermatologia, Modena
University Hospitals Cleveland Medical Center, Cleveland
Hospital Universitario y Politecnico La Fe, Valencia
The Indiana Clinical Trials Center, Plainfield
University of Muenster, Münster
Fachklinik Bad Bentheim, Bad Bentheim
Universitätsklinikum Bonn AöR, Bonn
Clinical Research Institute, Inc., Minneapolis
Health Concepts, Rapid City
NorthShore University HealthSystem, Skokie
Dundee Dermatology, West Dundee
IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung, Frankfurt
Great Lakes Clinical Trials, Chicago
Midwest Allergy Sinus Asthma, SC, Normal
Southern Illinois University School of Medicine, Springfield
Eukarya Pharmasite S.C., Monterrey
Meridian Clinical Research, LLC, Baton Rouge
Newton Clinical Research, Oklahoma City
Vital Prospects Clinical Research Institute, P.C., Tulsa
Arlington Research Center, Inc., Arlington
SMIQ. S. de R. L. de C.V., Querétaro
Center for Clinical Studies, LTD. LLP, Houston
Center for Clinical Studies, LTD. LLP, Webster
Austin Institute for Clinical Research, Inc., Austin
IMMUNOe Research Centers, Centennial
Idaho Allergy and Research, Eagle
ASR, LLC, Nampa
Jordan Valley Dermatology Center, West Jordan
Licca Clinical Research Institute, Augsburg
Studienzentrum Dr. med. Beate Schwarz, Langenau
Clinical Science Institute, Santa Monica
Allergy & Asthma Care Center of Southern California, Long Beach
MedDerm Associates, San Diego
Dermatology Specialists, Inc., Murrieta
Marvel Research, LLC, Huntington Beach
Alliance Research Centers, Laguna Hills
Allergy & Asthma Associates of Southern California dba Southern California Research, Mission Viejo
Synexus Clinical Research US, Inc., Santa Rosa
Portland Clinical Research dba Columbia Allergy & Asthma Clinic, Clackamas
Oregon Health & Science University (OHSU), Portland
Crisor, LLC, Medford
Centro Medico SkinMed Limitada, Santiago
Clinica Dermacross S.A., Santiago
MIRES (M y F Estudios Clínicos Limitada), Santiago
Centro Internacional de Estudios Clinicos - CIEC, Santiago
Skin Laser and Surgery Specialists of NY and NJ, Hackensack
Pacific Dermaesthetics Inc., Vancouver
Wiseman Dermatology Research Inc., Winnipeg
DermEffects, London
Lynderm Research Inc., Markham
North Bay Dermatology Centre, North Bay
SKiN Centre for Dermatology, Peterborough
Toronto Research Centre, Toronto
AvantDerm Clinical Research, Toronto
Manna Research (Toronto), Toronto
Innovaderm Research Inc., Montreal
Dr. Rachel Asiniwasis Medical Prof Corp, Regina
Dermamedica S.R.O., Náchod
CCR Ostrava, s.r.o., Ostrava
BENU Lekarna, Pardubice
CCR Czech, a.s., Pardubice
Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie, Pardubice
Lekarna U sv. Ignace, Prague
Synexus Czech, s.r.o., Prague
CCR Prague, s.r.o., Prague
Klinische Forschung Dresden GmbH, Dresden
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden, Dresden
Universitätsklinikum und Poliklinik für Dermatologie und Venerologie, Halle
SIBAmed Studienzentrum GmbH & Co KG, Leipzig
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore, Roma
Kawashima Dermatology Clinic, Ichikawa
Takagi Dermatological Clinic, Obihiro
Dermatology Shimizu Clinic, Kobe
Noguchi Dermatology Clinic, Kamimashiki-gun
Osaka Habikino Medical Center, Habikino
Kume Clinic, Sakai
Iidabashi Skin Clinic, Chiyoda-ku
Fukuwa Clinic, Chuo-ku
Tokyo Medical University Hospital, Shinjyuku-ku
Hoshikuma Dermatology・Allergy Clinic, Fukuoka
Matsuda Tomoko Dermatological Clinic, Fukuoka
Sanrui Hifuka, Saitama
Riga 1st Hospital, Clinic for Dermatology and STD, Riga
Aesthetic dermatology clinic of Prof. J. Kisis, Riga
Childrens Clinical University Hospital State SLLC, Riga
Health and aesthetics Ltd, Riga
Outpatient Clinic of Ventspils, Ventspils
Cryptex Investigación Clínica, S.A. de C.V., Cuauhtémoc
Arke Estudios Clinicos S.A. de C.V., Cuauhtémoc
"NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL", Bialystok
Centrum Medyczne SENSEMED, Chorzów
Synexus Polska Sp. z o.o. Oddzial w Czestochowie, Częstochowa
COPERNICUS-SZPITAL Oddzial Dermatologii, Gdansk
Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii, Gdansk
Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia
MCBK, Grodzisk Mazowiecki
Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
Care Clinic Centrum Medyczne, Katowice
Centrum Medyczne Angelius Provita, Katowice
Gabinet Dermatologiczny Beata Krecisz, Kielce
Centrum Medyczne Plejady, Krakow
AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc, Krakow
Krakowskie Centrum Medyczne Sp. z o.o., Krakow
Centrum Medyczne Promed, Krakow
Prywatna Praktyka Lekarska - Adam Smialowski, Ksawerów
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak, Lodz
Salve Medica Sp. z o.o. Sp. k., Lodz
KO-MED Centra Kliniczne Lublin II, Lublin
"NZOZ Med-Laser Borzecki Spolka Jawna", Lublin
Dermedic Jacek Zdybski, Ostrowiec Świętokrzyski
Synexus Polska Sp. z o.o. Oddzial w Poznaniu, Poznan
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k., Poznan
LIFT-MED Spolka Akcyjna, Rybnik
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii, Rzeszów
EMED Centrum Uslug Medycznych Ewa Smialek, Rzeszów
Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin
Medycyna Kliniczna, Warsaw
Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warsaw
MTZ Clinical Research Sp. z o.o., Warsaw
RCMed Oddzial Warszawa, Warsaw
Carpe Diem Centrum Medycyny Estetycznej, Warsaw
"REUMATIKA - Centrum Reumatologii NZOZ", Warsaw
Klinika Ambroziak Sp. z o.o., Warsaw
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej, Wroclaw
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw
"Lukasz Matusiak 4Health", Wroclaw
Centrum Medyczne Oporow, Wroclaw
SUMMIT CLINICAL RESEARCH, s.r.o., Bratislava
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kosice-Saca
Pedi-Derma s.r.o., Košice
Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika, Nové Zámky
SANARE spol. s.r.o., Dermatovenerologicka ambulancia, Svidník
Severance Hospital, Yonsei Univ. Health System, Seoul
Chung-Ang University Hospital, Seoul
Hallym University Kangnam Sacred Heart Hospital, Seoul
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Universitari Germans Trias i Pujol, Badalona
Medinova Research -West London Dedicated Research Centre, Wokingham
Derriford Hospital, Plymouth
Medinova Research, East London Dedicated Research Centre, Romford
Guy's Hospital-Guy's and St Thomas NHS Foundation Trust, London
Medinova Research, South London Clinical Trial Centre, Sidcup
MeDiNova Research North London Dedicated Research Centre, Northwood
Medinova Research, Yaxley
Medinova Research, Warwickshire Dedicated Research Centre, Kenilworth
Medinova, Yorkshire Quality Research Site, Shipley
MeDiNova Northamptonshire Dedicated Research Centre, Corby
West Glasgow ACH, NHS Greater Glasgow and Clyde, Glasgow
Lead Sponsor
Pfizer
INDUSTRY