Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Last updated: April 10, 2020
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Dermatitis, Atopic

Allergies & Asthma

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT03575871
B7451013
MONO-2
2018-001136-21
  • Ages > 12
  • All Genders

Study Summary

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Eligibility Criteria

Inclusion

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 moderateto severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRSseverity 4)

  • Recent history of inadequate response or inability to tolerate topical AD treatmentsor require systemic treatments for AD control

Exclusion

Exclusion Criteria:

  • Unwilling to discontinue current AD medications prior to the study or requiretreatment 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, Qwave interval abnormalities, current or history of certain infections, cancer,lymphoproliferative disorders and other medical conditions at the discretion of theinvestigator

  • Pregnant or breastfeeding women, or women of childbearing potential who are unwillingto use contraception

Study Design

Total Participants: 391
Study Start date:
June 29, 2018
Estimated Completion Date:
August 13, 2019

Connect with a study center

  • Australian Clinical Research Network

    Maroubra, New South Wales 2035
    Australia

    Site Not Available

  • The Skin Centre

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Skin and Cancer Foundation Inc

    Carlton, Victoria
    Australia

    Site Not Available

  • Sinclair Dermatology

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • The Royal Children's Hospital (RCH)

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Medical Centre Asklepii OOD

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

  • MHAT Dr. Tota Venkova AD

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • "Acibadem City Clinic MHAT Tokuda" EAD

    Sofia, 1407
    Bulgaria

    Site Not Available

  • "DCC Aleksandrovska" EOOD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Fokus-5

    Sofia, 1463
    Bulgaria

    Site Not Available

  • Medical Centre Synexus Sofia EOOD

    Sofia, 1784
    Bulgaria

    Site Not Available

  • University of British Columbia Department of Dermatology and Skin Science

    Vancouver, British Columbia V5Z 4E8
    Canada

    Site Not Available

  • Winnipeg Clinic

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Co-Medica Research Network Inc.

    East Oshawa, Ontario L1B 1B9
    Canada

    Site Not Available

  • North York Research Inc.

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Oshawa Clinic Dermatology Trials

    Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • The Second Affiliated Hospital of Army Medical University, PLA

    Chongqing, Chongqing 400037
    China

    Site Not Available

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong 518053
    China

    Site Not Available

  • Tianjin Medical University General Hospital, Dermatological Department

    Tianjin, 300052
    China

    Site Not Available

  • Dermamedica S.R.O.

    Nachod, 547 01
    Czechia

    Site Not Available

  • Lekarna u Stribrneho orla

    Nachod, 54701
    Czechia

    Site Not Available

  • Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni

    Nachod, 547 01
    Czechia

    Site Not Available

  • Sanatorium profesora Arenbergera

    Praha 1, 11000
    Czechia

    Site Not Available

  • Lekarna U sv. Ignace

    Praha 2, 120 00
    Czechia

    Site Not Available

  • Dermatologicka Ambulance

    Svitavy, 568 02
    Czechia

    Site Not Available

  • Lekarna na Hranicni

    Svitavy, 56802
    Czechia

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • ISA GmbH

    Berlin, 10789
    Germany

    Site Not Available

  • Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,

    Blankenfelde-Mahlow, 15831
    Germany

    Site Not Available

  • IKF Pneumologie GmbH & Co KG

    Frankfurt, 60596
    Germany

    Site Not Available

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253
    Germany

    Site Not Available

  • Comprehensive Center of Inflammation Medicine (CCIM), University Hospital of Schleswig-Holstein

    Lübeck, 23538
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis, Dres. Scholz, Sebastian, Schilling

    Mahlow, 15831
    Germany

    Site Not Available

  • Universitaet Muenster

    Münster, 48149
    Germany

    Site Not Available

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055
    Germany

    Site Not Available

  • Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete

    Budapest, 1195
    Hungary

    Site Not Available

  • SE AOK Bor, Nemikortani es Boronkologiai Klinika

    Budapest, 1085
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés

    Kecskemet, 6000
    Hungary

    Site Not Available

  • ALLERGO-DERM BAKOS Kft.

    Szolnok, 5000
    Hungary

    Site Not Available

  • Queen's square Medical Facilities Queen's square Dermatology and Allergology

    Yokohama, Kanagawa 220-6208
    Japan

    Site Not Available

  • Noguchi Dermatology Clinic

    Kamimashiki-gun, Kumamoto 861-3101
    Japan

    Site Not Available

  • Yoshioka Dermatology Clinic

    Neyagawa, Osaka 572-0838
    Japan

    Site Not Available

  • Kume Clinic

    Sakai, Osaka 593-8324
    Japan

    Site Not Available

  • Sumire Dermatology Clinic

    Edogawa-ku, Tokyo 133-0057
    Japan

    Site Not Available

  • Matsuyama Dermatology Clinic

    Nakano-ku, Tokyo 165-0026
    Japan

    Site Not Available

  • Hoshikuma Dermatology・Allergy Clinic

    Fukuoka, 814-0171
    Japan

    Site Not Available

  • Sanrui Hifuka

    Saitama, 330-0854
    Japan

    Site Not Available

  • Soon Chun Hyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do 14584
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan-si, Gyeongsangnam-do 50612
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Incheon St.Mary's Hospital

    Bupyeong-gu, Incheon 21431
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Jung-gu, Incheon 22332
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 61469
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Hallym university Kangnam Sacred Heart Hospital

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei Univ. Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Selga Freiberga private practice in dermatovenerology and cosmetology

    Jelgava, LV-3001
    Latvia

    Site Not Available

  • Aesthetic dermatology clinic of Prof. J. Kisis

    Riga, LV-1003
    Latvia

    Site Not Available

  • Health Centre 4 Ltd

    Riga, LV-1013
    Latvia

    Site Not Available

  • Health Centre 4 Ltd. Diagnostics Centre

    Riga, LV-1003
    Latvia

    Site Not Available

  • Riga 1st Hospital, Clinic for Dermatology and STD

    Riga, LV-1001
    Latvia

    Site Not Available

  • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.

    Bialystok, 15-453
    Poland

    Site Not Available

  • KLIMED Marek Klimkiewicz

    Białystok, 15-704
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.

    Krakow, 31-011
    Poland

    Site Not Available

  • Centrum Badań Klinicznych JCI

    Kraków, 30-348
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Kraków, 31-501
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, 90-242
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362
    Poland

    Site Not Available

  • Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.

    Poznan, 60-848
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Centrum Medyczne AMED

    Warszawa, 01-518
    Poland

    Site Not Available

  • Klinika Ambroziak Sp. z o.o.

    Warszawa, 02-758
    Poland

    Site Not Available

  • MTZ Clinical Research Sp. z o.o.

    Warszawa, 02-106
    Poland

    Site Not Available

  • Synexus Polska Sp. z o. o. Oddzial w Warszawie

    Warszawa, 01-192
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, 50-381
    Poland

    Site Not Available

  • Lukasz Matusiak "4HEALTH"

    Wrocław, 50-566
    Poland

    Site Not Available

  • Plymouth Hospitals NHS Trust, Derriford Hospital

    Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • MAC Clinical Research

    Bispham, Lancashire FY2 0JH
    United Kingdom

    Site Not Available

  • MAC Clinical Research

    Blackpool, Lancashire FY2 0JH
    United Kingdom

    Site Not Available

  • MAC Clinical Research Ltd

    Cannock, South Staffordshire WS11 0BN
    United Kingdom

    Site Not Available

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, South Yorkshire S75 2EP
    United Kingdom

    Site Not Available

  • University Hospital Bristol NHS Foundation Trust

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

  • MAC Clinical Research Ltd

    Manchester, M13 9NQ
    United Kingdom

    Site Not Available

  • Emmaus Research Center, Inc.

    Anaheim, California 92804
    United States

    Site Not Available

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • Advanced Research Center, Inc. - Los Alamitos Site

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Peninsula Research Associates, Inc.

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Colorado Springs Dermatology Clinic, PC

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Olympian Clinical Research

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Precision Imaging

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida 32801
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Imaging Center of Idaho

    Caldwell, Idaho 83605
    United States

    Site Not Available

  • ASR, LLC

    Nampa, Idaho 83687
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Meridian Clinical Research

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • MediSearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina 28411
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Ohio State University Dermatology East

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Tanenbaum Dermatology Center

    Memphis, Tennessee 38117
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc. - Central

    Austin, Texas 78705
    United States

    Site Not Available

  • Bellaire Dermatology Associates

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • West Houston Dermatology, PA

    Houston, Texas 77082
    United States

    Site Not Available

  • Summit Clinical Research, LLC

    Franklin, Virginia 23851
    United States

    Site Not Available

  • Virginia Dermatology and Skin Cancer Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

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