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.
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
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There are 147 Locations for this study
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35209, United States
Phoenix Arizona, 85032, United States
Fountain Valley California, 92708, United States
Long Beach California, 90806, United States
Long Beach California, 90808, United States
Los Angeles California, 90056, United States
Pomona California, 91767, United States
San Diego California, 92103, United States
San Diego California, 92122, United States
San Diego California, 92123, United States
San Francisco California, 94132, United States
Santa Ana California, 92705, United States
Santa Monica California, 90404, United States
Boca Raton Florida, 33486, United States
Largo Florida, 33770, United States
Miami Florida, 33173, United States
Orlando Florida, 32801, United States
Orlando Florida, 32819, United States
Tampa Florida, 33607, United States
Tampa Florida, 33614, United States
West Palm Beach Florida, 33406, United States
Norcross Georgia, 30093, United States
Normal Illinois, 61761, United States
West Dundee Illinois, 60118, United States
Indianapolis Indiana, 46250, United States
South Bend Indiana, 46617, United States
Overland Park Kansas, 66215, United States
Crowley Louisiana, 70526, United States
Brighton Massachusetts, 02135, United States
Flint Michigan, 48507, United States
Flint Michigan, 48532, United States
Fort Gratiot Michigan, 48059, United States
Royal Oak Michigan, 48067, United States
Troy Michigan, 48084, United States
Omaha Nebraska, 68144, United States
Las Vegas Nevada, 89148, United States
East Windsor New Jersey, 08520, United States
Rocky Mount North Carolina, 27804, United States
Shelby North Carolina, 28150, United States
Portland Oregon, 97223, United States
Philadelphia Pennsylvania, 19103, United States
Rapid City South Dakota, 57702, United States
Memphis Tennessee, 38119, United States
Murfreesboro Tennessee, 37130, United States
Houston Texas, 77004, United States
San Antonio Texas, 78229, United States
Sugar Land Texas, 77479, United States
West Jordan Utah, 84088, United States
Kogarah New South Wales, 2217, Australia
St Leonards New South Wales, 2065, Australia
Box Hill Victoria, 3128, Australia
Camberwell Victoria, 3124, Australia
Carlton Victoria, 3053, Australia
East Melbourne Victoria, 3002, Australia
Pakrville Victoria, 3050, Australia
Parkville Victoria, 3050, Australia
Dobrich , 9300, Bulgaria
Dupnitsa , 2600, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1463, Bulgaria
Sofia , 1606, Bulgaria
Calgary Alberta, T2J7E, Canada
Edmonton Alberta, T6G1C, Canada
Red Deer Alberta, T4P-1, Canada
Surrey British Columbia, V3R 6, Canada
Winnipeg Manitoba, R3M 3, Canada
St. John's Newfoundland and Labrador, A1A 4, Canada
Etobicoke Ontario, M8X 1, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L5H 1, Canada
North Bay Ontario, P1B 3, Canada
Oakville Ontario, L6J 7, Canada
Ottawa Ontario, K2C 3, Canada
Peterborough Ontario, K9J 5, Canada
Richmond Hill Ontario, L4B 1, Canada
Sudbury Ontario, P3A 1, Canada
Sudbury Ontario, P3C 1, Canada
Toronto Ontario, M3H5Y, Canada
Chicoutimi Quebec, G7H 7, Canada
Quebec , G1V 4, Canada
Quebec , G1W4R, Canada
Las Condes, Santiago Region Metropolitana, 75801, Chile
Nunoa, Santiago Region Metropolitana, 77504, Chile
Nunoa, Santiago Region Metropolitana, 77504, Chile
Santiago Region Metropolitana, 75009, Chile
Santiago Region Metropolitana, 75802, Chile
Santiago Region Metropolitana, 83804, Chile
Santiago Region Metropolitana, 84203, Chile
Santiago Región Metropolitana, 76408, Chile
Tampere , 33100, Finland
Turku , 20520, Finland
Turku , 20520, Finland
Bad Bentheim , 48455, Germany
Bielefeld , 33647, Germany
Dresden , 01069, Germany
Frankfurt am Main , 60596, Germany
Gera , 07548, Germany
Langenau , 89129, Germany
Leipzig , 04103, Germany
Lübeck , 23538, Germany
Mainz , 55128, Germany
Muenster , 48149, Germany
Budapest , 1033, Hungary
Debrecen , 4032, Hungary
Kaposvár , 7400, Hungary
Szeged , 6720, Hungary
Roma , 00168, Italy
Ansan-si Gyeonggi-do, 15355, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Incheon , 21431, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06973, Korea, Republic of
Riga , LV-10, Latvia
Riga , LV-10, Latvia
Ventspils , LV-36, Latvia
Bialystok , 15-45, Poland
Chorzow , 41-50, Poland
Gdansk , 80-21, Poland
Grodzisk Mazowiecki , 05-82, Poland
Katowice , 40-56, Poland
Krakow , 31-50, Poland
Krakow , 31-51, Poland
Lodz , 90-24, Poland
Lodz , 90-26, Poland
Ostrowiec Swietokrzyski , 27-40, Poland
Poznan , 61-44, Poland
Szczecin , 70-33, Poland
Szczecin , 71-43, Poland
Warszawa , 00-87, Poland
Warszawa , 02-10, Poland
Warszawa , 02-66, Poland
Wroclaw , 50-22, Poland
Wroclaw , 50-56, Poland
Wroclaw , 52-41, Poland
Zabrze , 41-80, Poland
Bratislava , 831 0, Slovakia
Bratislava , 83103, Slovakia
Bratislava , 841 0, Slovakia
Bratislava , 851 0, Slovakia
Nove Zamky , 940 3, Slovakia
Svidnik , 089 0, Slovakia
Badalona Barcelona, 08916, Spain
Barcelona , 08036, Spain
Madrid , 28046, Spain
Pontevedra , 36001, Spain
Pontevedra , 36071, Spain
Taipei City Taiwan (r.o.c), 11217, Taiwan
New Taipei City , 23561, Taiwan
Taipei , 100, Taiwan
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