Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

NCT ID: NCT03720470

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 838 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2020-03-06

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.

Conditions

Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg

Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20

Group Type: EXPERIMENTAL

PF-04965842 100 mg

Intervention Type: DRUG

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.

Injectable Placebo

Intervention Type: DRUG

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.

PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg

Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20

Group Type: EXPERIMENTAL

PF-04965842 200 mg

Intervention Type: DRUG

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.

Injectable Placebo

Intervention Type: DRUG

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.

Dupilumab Injection + Oral Placebo followed by Oral Placebo

Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20

Group Type: ACTIVE_COMPARATOR

Dupilumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Oral Placebo + Placebo Inj followed by 100 mg PF-04965842

Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20

Group Type: PLACEBO_COMPARATOR

PF-04965842 100 mg

Intervention Type: DRUG

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.

Oral Placebo

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Oral Placebo + Placebo Inj followed by 200 mg PF-04965842

Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20

Group Type: PLACEBO_COMPARATOR

PF-04965842 200 mg

Intervention Type: DRUG

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.

Oral Placebo

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

The University Of Alabama At Birmingham

Birmingham, Alabama, United States

Marvel Research, LLC

Huntington Beach, California, United States

Alliance Research Centers

Laguna Hills, California, United States

Allergy & Asthma Care Center of Southern California

Long Beach, California, United States

Allergy & Asthma Associates of Southern California dba Southern California Research

Mission Viejo, California, United States

Dermatology Specialists, Inc.

Murrieta, California, United States

MedDerm Associates

San Diego, California, United States

Clinical Science Institute

Santa Monica, California, United States

Synexus Clinical Research US, Inc.

Santa Rosa, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Renaissance Research and Medical Group, Inc

Cape Coral, Florida, United States

C & R Research Services USA, Inc

Coral Gables, Florida, United States

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, United States

Moonshine Research Center, Inc.

Doral, Florida, United States

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, United States

Olympian Clinical Research

Largo, Florida, United States

Savin Medical Group LLC

Miami, Florida, United States

Wellness Clinical Research, LLC

Miami Lakes, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Research Institute of Southeast, LLC

West Palm Beach, Florida, United States

Research Institute of the Southeast, LLC

West Palm Beach, Florida, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

Idaho Allergy and Research

Eagle, Idaho, United States

ASR, LLC

Nampa, Idaho, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Midwest Allergy Sinus Asthma, SC

Normal, Illinois, United States

NorthShore University HealthSystem

Skokie, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Forefront Dermatology, S.C.

Louisville, Kentucky, United States

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States

Clinical Research Institute, Inc.

Minneapolis, Minnesota, United States

Skin Laser and Surgery Specialists of NY and NJ

Hackensack, New Jersey, United States

Forest Hills Dermatology Group

Kew Gardens, New York, United States

Juva Skin and Laser Center

New York, New York, United States

TrialSpark, Inc (Russell Cohen)

Oceanside, New York, United States

Cary Dermatology Center, PA

Cary, North Carolina, United States

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

Cary, North Carolina, United States

Medication Management, LLC

Greensboro, North Carolina, United States

PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare

Statesville, North Carolina, United States

Winston-Salem Dermatology and Surgery Center, PLLC

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Newton Clinical Research

Oklahoma City, Oklahoma, United States

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, United States

Portland Clinical Research dba Columbia Allergy & Asthma Clinic

Clackamas, Oregon, United States

Crisor, LLC

Medford, Oregon, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, United States

Synexus Clinical Research US, Inc.

Anderson, South Carolina, United States

Synexus Clinical Research US. Inc.

Greer, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Arlington Research Center, Inc.

Arlington, Texas, United States

Austin Institute for Clinical Research, Inc.

Austin, Texas, United States

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States

Jordan Valley Dermatology Center

West Jordan, Utah, United States

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States

Velocity Urgent Care

Norfolk, Virginia, United States

Woden Dermatology

Phillip, Australian Capital Territory, Australia

Australian Clinical Research Network

Maroubra, New South Wales, Australia

The Skin Centre

Benowa, Queensland, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

North Eastern Health Specialists

Hectorville, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Emeritus Research

Camberwell, Victoria, Australia

Skin and Cancer Foundation Inc

Carlton, Victoria, Australia

Sinclair Dermatology

East Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

DCC 2/Sofia EOOD

Sofia, , Bulgaria

"DCC Aleksandrovska" EOOD

Sofia, , Bulgaria

Dermatology Clinic "Sofia" Ltd

Sofia, , Bulgaria

"Mc Synexus Sofia" Eood

Sofia, , Bulgaria

Medical Centre Synexus Sofia EOOD-branch Stara Zagora

Stara Zagora, , Bulgaria

"DCC "Mladost-M Varna" OOD

Varna, , Bulgaria

Pacific Dermaesthetics Inc.

Vancouver, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

DermEffects

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

AvantDerm Clinical Research

Toronto, Ontario, Canada

Manna Research (Toronto)

Toronto, Ontario, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Dr. Rachel Asiniwasis Medical Prof Corp

Regina, Saskatchewan, Canada

Centro Medico SkinMed Limitada

Santiago, Santiago Metropolitan, Chile

Clinica Dermacross S.A.

Santiago, Santiago Metropolitan, Chile

MIRES (M y F Estudios Clínicos Limitada)

Santiago, Santiago Metropolitan, Chile

Centro Internacional de Estudios Clinicos - CIEC

Santiago, Santiago Metropolitan, Chile

Dermamedica S.R.O.

Náchod, , Czechia

CCR Ostrava, s.r.o.

Ostrava, , Czechia

BENU Lekarna

Pardubice, , Czechia

CCR Czech, a.s.

Pardubice, , Czechia

Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie

Pardubice, , Czechia

Sanatorium profesora Arenbergera

Prague, , Czechia

Lekarna U sv. Ignace

Prague, , Czechia

Synexus Czech, s.r.o.

Prague, , Czechia

CCR Prague, s.r.o.

Prague, , Czechia

Licca Clinical Research Institute

Augsburg, , Germany

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Klinikum Bielefeld Rosenhohe

Bielefeld, , Germany

Universitätsklinikum Bonn AöR

Bonn, , Germany

Klinische Forschung Dresden GmbH

Dresden, , Germany

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

Dresden, , Germany

IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung

Frankfurt, , Germany

Universitätsklinikum und Poliklinik für Dermatologie und Venerologie

Halle, , Germany

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Studienzentrum Dr. med. Beate Schwarz

Langenau, , Germany

SIBAmed Studienzentrum GmbH & Co KG

Leipzig, , Germany

Universitaetsklinikum Schleswig-Holstein/Campus Luebeck

Lübeck, , Germany

Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling

Mahlow, , Germany

Universitätsklinikum Marburg

Marburg, , Germany

University of Muenster

Münster, , Germany

SE AOK Bor-, Nemikortani es Boronkologiai Klinika

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS

Gyula, , Hungary

Trial Pharma Kft.

Püspökladány, , Hungary

Medmare Bt

Veszprém, , Hungary

Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore

Roma, RM, Italy

AOU Policlinico di Modena, Struttura Complessa di Dermatologia

Modena, , Italy

Kawashima Dermatology Clinic

Ichikawa, Chiba, Japan

Takagi Dermatological Clinic

Obihiro, Hokkaido, Japan

Dermatology Shimizu Clinic

Kobe, Hyōgo, Japan

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto, Japan

Osaka Habikino Medical Center

Habikino, Osaka, Japan

Kume Clinic

Sakai, Osaka, Japan

Iidabashi Skin Clinic

Chiyoda-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjyuku-ku, Tokyo, Japan

Hoshikuma Dermatology・Allergy Clinic

Fukuoka, , Japan

Matsuda Tomoko Dermatological Clinic

Fukuoka, , Japan

Sanrui Hifuka

Saitama, , Japan

Riga 1st Hospital, Clinic for Dermatology and STD

Riga, , Latvia

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, , Latvia

Childrens Clinical University Hospital State SLLC

Riga, , Latvia

Health and aesthetics Ltd

Riga, , Latvia

Outpatient Clinic of Ventspils

Ventspils, , Latvia

Cryptex Investigación Clínica, S.A. de C.V.

Cuauhtémoc, Mexico City, Mexico

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

Cuauhtémoc, Mexico City, Mexico

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, Mexico

SMIQ. S. de R. L. de C.V.

Querétaro, , Mexico

NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"

Bialystok, , Poland

Centrum Medyczne SENSEMED

Chorzów, , Poland

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Częstochowa, , Poland

COPERNICUS-SZPITAL Oddzial Dermatologii

Gdansk, , Poland

Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii

Gdansk, , Poland

Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, , Poland

MCBK

Grodzisk Mazowiecki, , Poland

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, , Poland

Care Clinic Centrum Medyczne

Katowice, , Poland

Centrum Medyczne Angelius Provita

Katowice, , Poland

Gabinet Dermatologiczny Beata Krecisz

Kielce, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc

Krakow, , Poland

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, , Poland

Centrum Medyczne Promed

Krakow, , Poland

Prywatna Praktyka Lekarska - Adam Smialowski

Ksawerów, , Poland

Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak

Lodz, , Poland

Salve Medica Sp. z o.o. Sp. k.

Lodz, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

NZOZ "Med-Laser" Borzecki Spolka Jawna

Lublin, , Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, , Poland

Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, , Poland

Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.

Poznan, , Poland

LIFT-MED Spolka Akcyjna

Rybnik, , Poland

Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii

Rzeszów, , Poland

EMED Centrum Uslug Medycznych Ewa Smialek

Rzeszów, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Medycyna Kliniczna

Warsaw, , Poland

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

Warsaw, , Poland

MTZ Clinical Research Sp. z o.o.

Warsaw, , Poland

RCMed Oddzial Warszawa

Warsaw, , Poland

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, , Poland

"REUMATIKA - Centrum Reumatologii" NZOZ

Warsaw, , Poland

Klinika Ambroziak Sp. z o.o.

Warsaw, , Poland

EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

Wroclaw, , Poland

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

Wroclaw, , Poland

Lukasz Matusiak "4Health"

Wroclaw, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

SUMMIT CLINICAL RESEARCH, s.r.o.

Bratislava, , Slovakia

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

Kosice-Saca, , Slovakia

Pedi-Derma s.r.o.

Košice, , Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika

Nové Zámky, , Slovakia

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

Svidník, , Slovakia

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Chungnam National University Hospital CNUH

Daejeon, , South Korea

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

Incheon, , South Korea

Severance Hospital, Yonsei Univ. Health System

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario y Politecnico La Fe

Valencia, , Spain

Taipei Veterans General Hospital

Taipei, Taiwan (r.o.c), Taiwan

Chung Shan Medical University Hospital (CSMUH)

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Cheng-Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Medinova Research -West London Dedicated Research Centre

Wokingham, Berkshire, United Kingdom

Derriford Hospital

Plymouth, Devon, United Kingdom

Medinova Research, East London Dedicated Research Centre

Romford, Essex, United Kingdom

Guy's Hospital-Guy's and St Thomas NHS Foundation Trust

London, Greater London, United Kingdom

Medinova Research, South London Clinical Trial Centre

Sidcup, KENT, United Kingdom

MeDiNova Research North London Dedicated Research Centre

Northwood, Middlesex, United Kingdom

Medinova Research

Yaxley, Peterborough, United Kingdom

Medinova Research, Warwickshire Dedicated Research Centre

Kenilworth, Warwickshire, United Kingdom

Medinova, Yorkshire Quality Research Site

Shipley, WEST Yorkshire, United Kingdom

MeDiNova Northamptonshire Dedicated Research Centre

Corby, , United Kingdom

West Glasgow ACH, NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Countries

United States; Australia; Bulgaria; Canada; Chile; Czechia; Germany; Hungary; Italy; Japan; Latvia; Mexico; Poland; Slovakia; South Korea; Spain; Taiwan; United Kingdom

References

Simpson EL, Silverberg JI, Geng B, Carrascosa JM, Bieber T, Brunner PM, Staumont-Salle D, Ji C, Biswas P, Feeney C, Hernandez-Martin I, Rebollo Laserna FJ, Koppensteiner H. Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis? Dermatol Ther (Heidelb). 2025 Nov;15(11):3391-3407. doi: 10.1007/s13555-025-01516-w. Epub 2025 Sep 23.

Reference Type: DERIVED

PMID: 40987931 (View on PubMed)

Silverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug.

Reference Type: DERIVED

PMID: 39104653 (View on PubMed)

Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.

Reference Type: DERIVED

PMID: 38896380 (View on PubMed)

Simpson EL, Silverberg JI, Thyssen JP, Viguier M, Thaci D, de Bruin-Weller M, Weidinger S, Chan G, DiBonaventura M, Biswas P, Feeney C, Koulias C, Cork MJ. Efficacy and Safety of Abrocitinib in Patients with Severe and/or Difficult-to-Treat Atopic Dermatitis: A Post Hoc Analysis of the Randomized Phase 3 JADE COMPARE Trial. Am J Clin Dermatol. 2023 Jul;24(4):609-621. doi: 10.1007/s40257-023-00785-5. Epub 2023 May 22.

Reference Type: DERIVED

PMID: 37213005 (View on PubMed)

Stander S, Kwatra SG, Silverberg JI, Simpson EL, Thyssen JP, Yosipovitch G, Zhang F, Cameron MC, Cella RR, Valdez H, DiBonaventura M, Feeney C. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Am J Clin Dermatol. 2023 Jan;24(1):97-107. doi: 10.1007/s40257-022-00738-4. Epub 2022 Dec 13.

Reference Type: DERIVED

PMID: 36512175 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36108923 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35297025 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34775830 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34406619 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33761207 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7451029

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Other Identifiers

COMPARE

Identifier Type: OTHER

Identifier Source: secondary_id

2018-002573-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7451029

Identifier Type: -

Identifier Source: org_study_id