Psoriasis Clinical Trial

Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Summary

This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease

Exclusion Criteria:

Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
Have increased risk of developing venous thromboembolism
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
Other active non-AD inflammatory skin diseases or conditions affecting skin
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

727

Study ID:

NCT04345367

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 147 Locations for this study

See Locations Near You

Total Skin & Beauty Dermatology Center, PC
Birmingham Alabama, 35205, United States
Clinical Research Center Of Alabama
Birmingham Alabama, 35209, United States
Alliance Dermatology & MOHS Center, PC
Phoenix Arizona, 85032, United States
First OC Dermatology
Fountain Valley California, 92708, United States
Ark Clinical Research
Long Beach California, 90806, United States
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach California, 90808, United States
Wallace Medical Group, Inc
Los Angeles California, 90056, United States
Empire Clinical Research
Pomona California, 91767, United States
MedDerm Associates
San Diego California, 92103, United States
University of California San Diego Dermatology
San Diego California, 92122, United States
University Clinical Trials Inc.
San Diego California, 92123, United States
Synergy Dermatology
San Francisco California, 94132, United States
Wolverine Clinical Trials, Llc
Santa Ana California, 92705, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Skin Care Research, LLC
Boca Raton Florida, 33486, United States
Olympian Clinical Research
Largo Florida, 33770, United States
Miami Dermatology & Laser Research, LLC
Miami Florida, 33173, United States
Clinical Neuroscience Solutions, Inc.
Orlando Florida, 32801, United States
Accel Research Sites - Pure Skin Dermatology & Aesthetics
Orlando Florida, 32819, United States
Clinical Research Trials of Florida, Inc.
Tampa Florida, 33607, United States
Olympian Clinical Research
Tampa Florida, 33614, United States
Integrated Clinical Research
West Palm Beach Florida, 33406, United States
One Health Research Clinic
Norcross Georgia, 30093, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal Illinois, 61761, United States
Dundee Dermatology
West Dundee Illinois, 60118, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States
The South Bend Clinic Center for Research
South Bend Indiana, 46617, United States
Epiphany Dermatology of Kansas, LLC
Overland Park Kansas, 66215, United States
Avant Research Associates, LLC
Crowley Louisiana, 70526, United States
MetroBoston Clinical Partners, LLC
Brighton Massachusetts, 02135, United States
Onyx Clinical Research
Flint Michigan, 48507, United States
Linden Road Imaging Center
Flint Michigan, 48532, United States
Hamzavi Dermatology
Fort Gratiot Michigan, 48059, United States
Regional Medical Imaging, P.C. ( Local X-Ray)
Royal Oak Michigan, 48067, United States
Revival Research Institute, LLC
Troy Michigan, 48084, United States
Skin Specialists, PC
Omaha Nebraska, 68144, United States
Vivida Dermatology
Las Vegas Nevada, 89148, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Boice-Willis Clinic, PA
Rocky Mount North Carolina, 27804, United States
Carolina Research Center, Inc.
Shelby North Carolina, 28150, United States
Oregon Medical Research Center
Portland Oregon, 97223, United States
Paddington Testing Co, Inc.
Philadelphia Pennsylvania, 19103, United States
Health Concepts
Rapid City South Dakota, 57702, United States
Clinical Neuroscience Solutions, Inc.
Memphis Tennessee, 38119, United States
International Clinical Research - Tennessee LLC
Murfreesboro Tennessee, 37130, United States
Center for Clinical Studies, LTD. LLP
Houston Texas, 77004, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 78229, United States
Acclaim Dermatology, PLLC
Sugar Land Texas, 77479, United States
Jordan Valley Dermatology Center
West Jordan Utah, 84088, United States
St George Dermatology and Skin Cancer Centre
Kogarah New South Wales, 2217, Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Emeritus Research
Camberwell Victoria, 3124, Australia
Skin Health Institute Inc.
Carlton Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne Victoria, 3002, Australia
Melbourne Health Radiology
Pakrville Victoria, 3050, Australia
The Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
MHAT Dobrich AD
Dobrich , 9300, Bulgaria
MC Asklepii OOD
Dupnitsa , 2600, Bulgaria
DCC Alexandrovska EOOD
Sofia , 1431, Bulgaria
DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD
Sofia , 1463, Bulgaria
Military Medical Academy MHAT Sofia
Sofia , 1606, Bulgaria
Dermatology Research Institute
Calgary Alberta, T2J7E, Canada
Alberta DermaSurgery Centre
Edmonton Alberta, T6G1C, Canada
CARE Clinic Ltd
Red Deer Alberta, T4P-1, Canada
Dr. Chih-ho Hong Medical Inc
Surrey British Columbia, V3R 6, Canada
Wiseman Dermatology Research Inc.
Winnipeg Manitoba, R3M 3, Canada
Karma Clinical Trials, Inc.
St. John's Newfoundland and Labrador, A1A 4, Canada
Kingsway Clinical Research
Etobicoke Ontario, M8X 1, Canada
DermEffects
London Ontario, N6H 5, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
DermEdge Research
Mississauga Ontario, L5H 1, Canada
North Bay Dermatology Centre
North Bay Ontario, P1B 3, Canada
The Centre for Clinical Trials
Oakville Ontario, L6J 7, Canada
Dermatology Ottawa Research Centre
Ottawa Ontario, K2C 3, Canada
SKiN Centre for Dermatology
Peterborough Ontario, K9J 5, Canada
The Centre for Dermatology
Richmond Hill Ontario, L4B 1, Canada
Medicor Research Inc
Sudbury Ontario, P3A 1, Canada
Sudbury Skin Clinique
Sudbury Ontario, P3C 1, Canada
Toronto Research Centre
Toronto Ontario, M3H5Y, Canada
Intermed groupe santé
Chicoutimi Quebec, G7H 7, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Quebec , G1V 4, Canada
Centre de Recherche Saint-Louis
Quebec , G1W4R, Canada
Medicien
Las Condes, Santiago Region Metropolitana, 75801, Chile
MIRES (M Y F Estudios Clinicos Limitada)
Nunoa, Santiago Region Metropolitana, 77504, Chile
Vida lntegra
Nunoa, Santiago Region Metropolitana, 77504, Chile
Centro Radiologico Plaza Baquedano
Santiago Region Metropolitana, 75009, Chile
Centro Medico SkinMed Limitada
Santiago Region Metropolitana, 75802, Chile
Hospital Clinico Universidad de Chile
Santiago Region Metropolitana, 83804, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago Region Metropolitana, 84203, Chile
Clínica Dermacross S.A.
Santiago Región Metropolitana, 76408, Chile
Terveystalo Tampere
Tampere , 33100, Finland
Mehiläinen Neo
Turku , 20520, Finland
Turun yliopistollinen keskussairaala
Turku , 20520, Finland
Fachklinik Bad Bentheim
Bad Bentheim , 48455, Germany
Klinikum Bielefeld Rosenhöhe
Bielefeld , 33647, Germany
Klinische Forschung Dresden GmbH
Dresden , 01069, Germany
IKF Pneumologie GmbH & Co KG
Frankfurt am Main , 60596, Germany
SRH Wald-Klinikum Gera GmbH
Gera , 07548, Germany
Studienzentrum Dr. med. Beate Schwarz
Langenau , 89129, Germany
SIBAmed GmbH
Leipzig , 04103, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck , 23538, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz , 55128, Germany
University of Muenster
Muenster , 48149, Germany
Clinexpert Kft.
Budapest , 1033, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen , 4032, Hungary
Trial Pharma Kft.
Kaposvár , 7400, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged , 6720, Hungary
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
Roma , 00168, Italy
Korea University Ansan Hospital
Ansan-si Gyeonggi-do, 15355, Korea, Republic of
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon , 21431, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Chung-Ang University Hospital
Seoul , 06973, Korea, Republic of
Health Centre 4 Ltd. Diagnostics Centre
Riga , LV-10, Latvia
LLC J.Kisis
Riga , LV-10, Latvia
Outpatient Clinic of Ventspils
Ventspils , LV-36, Latvia
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
Bialystok , 15-45, Poland
DERMAPOLIS Medical Dermatology Center
Chorzow , 41-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
MCBK
Grodzisk Mazowiecki , 05-82, Poland
Care Clinic Centrum Medyczne
Katowice , 40-56, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow , 31-50, Poland
Centrum Medyczne Promed
Krakow , 31-51, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz , 90-24, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne
Lodz , 90-26, Poland
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski , 27-40, Poland
Gabinety Lekarskie Rivermed
Poznan , 61-44, Poland
Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic"
Szczecin , 70-33, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin , 71-43, Poland
Medycyna Kliniczna
Warszawa , 00-87, Poland
MTZ Clinical Research Sp. z o.o.
Warszawa , 02-10, Poland
Carpe Diem Centrum Medycyny Estetycznej
Warszawa , 02-66, Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw , 50-22, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw , 50-56, Poland
Centrum Medyczne Oporow
Wroclaw , 52-41, Poland
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
Zabrze , 41-80, Poland
SUMMIT CLINICAL RESEARCH, s.r.o.
Bratislava , 831 0, Slovakia
SKINKLINIK s.r.o
Bratislava , 83103, Slovakia
BeneDerma s.r.o.
Bratislava , 841 0, Slovakia
Derma therapy spol. s.r.o.
Bratislava , 851 0, Slovakia
Dermatovenerologicka ambulancia
Nove Zamky , 940 3, Slovakia
SANARE spol.s.r.o.
Svidnik , 089 0, Slovakia
Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)
Pontevedra , 36001, Spain
Hospital de Montecelo
Pontevedra , 36071, Spain
Taipei Veterans General Hospital
Taipei City Taiwan (r.o.c), 11217, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City , 23561, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

727

Study ID:

NCT04345367

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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