Clinical trial NCT03720470: Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Keywords: atopic dermatitis
atopic eczema
eczema
JAK
janus kinase
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 838
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy 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. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 years or older at the time of informed consent
* Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
* Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
* Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

  1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
  2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
* Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

  * Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  * Have medically confirmed ovarian failure; or
  * Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study

Exclusion Criteria:

* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
* 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
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Other active nonAD inflammatory skin diseases or conditions affecting skin
* Prior treatment with JAK inhibitors
* Previous treatment with dupilumab
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Primary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12
timeFrame: Baseline (the last measurement prior to first dosing on Day 1), Week 12
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
measure: Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16
timeFrame: Baseline, Week 2, 4, 8 and 16
measure: Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16
timeFrame: Baseline, Week 2, 4, 8 and 16
measure: Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, 4, 8, 12 and 16
measure: Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, 4, 8,12 and 16
measure: Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, 4, 8, 12 and 16
measure: Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, 4, 8, 12 and 16
measure: Percentage BSA at Week 18 and 20
timeFrame: Week 18 and 20
measure: Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, 4, 8, 12 and 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16
timeFrame: Baseline, Week 2, 12 and 16
measure: DLQI at Week 20
timeFrame: Week 20
measure: Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16
timeFrame: Baseline, Week 12 and 16
measure: Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16
timeFrame: Baseline, Week 12 and 16
measure: EQ-5D-5L- Index Value at Week 20
timeFrame: Week 20
measure: EQ-5D-5L- VAS Score at Week 20
timeFrame: Week 20
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16
timeFrame: Baseline, Weeks 12 and 16
measure: Change From Baseline in HADS - Depression Scale at Week 12 and 16
timeFrame: Baseline, Week 12 and 16
measure: HADS - Anxiety Scale at Week 20
timeFrame: Week 20
measure: HADS - Depression Scale at Week 20
timeFrame: Week 20
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16
timeFrame: Baseline, Week 12 and 16
measure: POEM at Week 20
timeFrame: Week 20
measure: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16
timeFrame: Baseline, Week 1 to Week 16
measure: PSAAD Total Score at Week 18 and 20
timeFrame: Week 18 and 20
measure: Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, 4, 8 12 and 16
measure: Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16
timeFrame: Baseline, Week 2, 4, 8 12 and 16
measure: Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16
timeFrame: Baseline, Week 2, 4, 8 12 and 16
measure: SCORAD VAS of Itch and Sleep Loss at Week 18 and 20
timeFrame: Week 18 and 20
measure: Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Birmingham
country: United States
facility: The University Of Alabama At Birmingham
state: Alabama
city: Huntington Beach
country: United States
facility: Marvel Research, LLC
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Care Center of Southern California
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California dba Southern California Research
state: California
city: Murrieta
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Santa Rosa
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group, Inc
state: Florida
city: Coral Gables
country: United States
facility: C & R Research Services USA, Inc
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Doral
country: United States
facility: Moonshine Research Center, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Savin Medical Group LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of Southeast, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy and Research
state: Idaho
city: Nampa
country: United States
facility: ASR, LLC
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Normal
country: United States
facility: Midwest Allergy Sinus Asthma, SC
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: Forefront Dermatology, S.C.
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NY and NJ
state: New Jersey
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Juva Skin and Laser Center
state: New York
city: Oceanside
country: United States
facility: TrialSpark, Inc (Russell Cohen)
state: New York
city: Cary
country: United States
facility: Cary Dermatology Center, PA
state: North Carolina
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Statesville
country: United States
facility: PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
state: North Carolina
city: Winston-Salem
country: United States
facility: Winston-Salem Dermatology and Surgery Center, PLLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Newton Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Clackamas
country: United States
facility: Portland Clinical Research dba Columbia Allergy & Asthma Clinic
state: Oregon
city: Medford
country: United States
facility: Crisor, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc.
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Greer
country: United States
facility: Synexus Clinical Research US. Inc.
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Norfolk
country: United States
facility: Velocity Urgent Care
state: Virginia
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Hectorville
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Carlton
country: Australia
facility: Skin and Cancer Foundation Inc
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Sofia
country: Bulgaria
facility: DCC 2/Sofia EOOD
city: Sofia
country: Bulgaria
facility: "DCC Aleksandrovska" EOOD
city: Sofia
country: Bulgaria
facility: Dermatology Clinic "Sofia" Ltd
city: Sofia
country: Bulgaria
facility: "Mc Synexus Sofia" Eood
city: Stara Zagora
country: Bulgaria
facility: Medical Centre Synexus Sofia EOOD-branch Stara Zagora
city: Varna
country: Bulgaria
facility: "DCC "Mladost-M Varna" OOD
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Manna Research (Toronto)
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Regina
country: Canada
facility: Dr. Rachel Asiniwasis Medical Prof Corp
state: Saskatchewan
city: Santiago
country: Chile
facility: Centro Medico SkinMed Limitada
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica Dermacross S.A.
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC
state: Region Metropolitana
city: Santiago
country: Chile
facility: MIRES (M y F Estudios Clínicos Limitada)
state: Región Metropolitana
city: Nachod
country: Czechia
facility: Dermamedica S.R.O.
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o.
city: Pardubice
country: Czechia
facility: BENU Lekarna
city: Pardubice
country: Czechia
facility: CCR Czech, a.s.
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie
city: Praha 1
country: Czechia
facility: Sanatorium profesora Arenbergera
city: Praha 2
country: Czechia
facility: Lekarna U sv. Ignace
city: Praha 2
country: Czechia
facility: Synexus Czech, s.r.o.
city: Praha 3
country: Czechia
facility: CCR Prague, s.r.o.
city: Augsburg
country: Germany
facility: Licca Clinical Research Institute
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhohe
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
city: Frankfurt
country: Germany
facility: IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung
city: Halle
country: Germany
facility: Universitätsklinikum und Poliklinik für Dermatologie und Venerologie
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Langenau
country: Germany
facility: Studienzentrum Dr. med. Beate Schwarz
city: Leipzig
country: Germany
facility: SIBAmed Studienzentrum GmbH & Co KG
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
city: Muenster
country: Germany
facility: University of Muenster
city: Budapest
country: Hungary
facility: SE AOK Bor-, Nemikortani es Boronkologiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS
city: Püspökladány
country: Hungary
facility: Trial Pharma Kft.
city: Veszprem
country: Hungary
facility: Medmare Bt
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
state: RM
city: Modena
country: Italy
facility: AOU Policlinico di Modena, Struttura Complessa di Dermatologia
city: Ichikawa
country: Japan
facility: Kawashima Dermatology Clinic
state: Chiba
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Kobe
country: Japan
facility: Dermatology Shimizu Clinic
state: Hyogo
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology Clinic
state: Kumamoto
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Sakai
country: Japan
facility: Kume Clinic
state: Osaka
city: Chiyoda-ku
country: Japan
facility: Iidabashi Skin Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Hoshikuma Dermatology・Allergy Clinic
city: Fukuoka
country: Japan
facility: Matsuda Tomoko Dermatological Clinic
city: Saitama
country: Japan
facility: Sanrui Hifuka
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital CNUH
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei Univ. Health System
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Riga
country: Latvia
facility: Riga 1st Hospital, Clinic for Dermatology and STD
city: Riga
country: Latvia
facility: Aesthetic dermatology clinic of Prof. J. Kisis
city: Riga
country: Latvia
facility: Childrens Clinical University Hospital State SLLC
city: Riga
country: Latvia
facility: Health and aesthetics Ltd
city: Ventspils
country: Latvia
facility: Outpatient Clinic of Ventspils
city: Cuauhtemoc
country: Mexico
facility: Cryptex Investigación Clínica, S.A. de C.V.
state: Mexico CITY
city: Cuauhtemoc
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
state: Mexico CITY
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite S.C.
state: Nuevo LEON
city: Queretaro
country: Mexico
facility: SMIQ. S. de R. L. de C.V.
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"
city: Chorzow
country: Poland
facility: Centrum Medyczne SENSEMED
city: Czestochowa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
city: Gdansk
country: Poland
facility: COPERNICUS-SZPITAL Oddzial Dermatologii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Grodzisk Mazowiecki
country: Poland
facility: MCBK
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Katowice
country: Poland
facility: Care Clinic Centrum Medyczne
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Kielce
country: Poland
facility: Gabinet Dermatologiczny Beata Krecisz
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Ksawerow
country: Poland
facility: Prywatna Praktyka Lekarska - Adam Smialowski
city: Lodz
country: Poland
facility: Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
city: Lodz
country: Poland
facility: Salve Medica Sp. z o.o. Sp. k.
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Lublin
country: Poland
facility: NZOZ "Med-Laser" Borzecki Spolka Jawna
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu
city: Poznan
country: Poland
facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
city: Rybnik
country: Poland
facility: LIFT-MED Spolka Akcyjna
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii
city: Rzeszow
country: Poland
facility: EMED Centrum Uslug Medycznych Ewa Smialek
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: RCMed Oddzial Warszawa
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: "REUMATIKA - Centrum Reumatologii" NZOZ
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. z o.o.
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Wroclaw
country: Poland
facility: Lukasz Matusiak "4Health"
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Bratislava
country: Slovakia
facility: SUMMIT CLINICAL RESEARCH, s.r.o.
city: Kosice-Saca
country: Slovakia
facility: Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica
city: Kosice
country: Slovakia
facility: Pedi-Derma s.r.o.
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika
city: Svidnik
country: Slovakia
facility: SANARE spol. s.r.o., Dermatovenerologicka ambulancia
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taiwan (r.o.c)
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital (CSMUH)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Wokingham
country: United Kingdom
facility: Medinova Research -West London Dedicated Research Centre
state: Berkshire
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Romford
country: United Kingdom
facility: Medinova Research, East London Dedicated Research Centre
state: Essex
city: London
country: United Kingdom
facility: Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
state: Greater London
city: Sidcup
country: United Kingdom
facility: Medinova Research, South London Clinical Trial Centre
state: Kent
city: Northwood
country: United Kingdom
facility: MeDiNova Research North London Dedicated Research Centre
state: Middlesex
city: Yaxley
country: United Kingdom
facility: Medinova Research
state: Peterborough
city: Kenilworth
country: United Kingdom
facility: Medinova Research, Warwickshire Dedicated Research Centre
state: Warwickshire
city: Shipley
country: United Kingdom
facility: Medinova, Yorkshire Quality Research Site
state: WEST Yorkshire
city: Corby
country: United Kingdom
facility: MeDiNova Northamptonshire Dedicated Research Centre
city: Glasgow
country: United Kingdom
facility: West Glasgow ACH, NHS Greater Glasgow and Clyde
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Reich K, Lio PA, Bissonnette R, Alexis AF, Lebwohl MG, Pink AE, Kabashima K, Boguniewicz M, Nowicki RJ, Valdez H, Zhang F, DiBonaventura M, Cameron MC, Clibborn C. Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2022 Dec;10(12):3228-3237.e2. doi: 10.1016/j.jaip.2022.08.042. Epub 2022 Sep 13.
citation: Alexis A, de Bruin-Weller M, Weidinger S, Soong W, Barbarot S, Ionita I, Zhang F, Valdez H, Clibborn C, Yin N. Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study. Dermatol Ther (Heidelb). 2022 Mar;12(3):771-785. doi: 10.1007/s13555-022-00694-1. Epub 2022 Mar 17.
citation: Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H. Comparing abrocitinib and dupilumab in the treatment of atopic dermatitis: a plain language summary. Immunotherapy. 2022 Jan;14(1):5-14. doi: 10.2217/imt-2021-0224. Epub 2021 Nov 15.
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.
citation: Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H; JADE COMPARE Investigators. Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis. N Engl J Med. 2021 Mar 25;384(12):1101-1112. doi: 10.1056/NEJMoa2019380.