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A Study Evaluating APG777 in Atopic Dermatitis
Sponsor: Apogee Therapeutics, Inc.
Summary
This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.
Official title: A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
470
Start Date
2024-04-29
Completion Date
2028-06
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
APG777
APG777 subcutaneous injection
Placebo
Matching placebo subcutaneous injection
Locations (94)
Investigational Site
Fountain Valley, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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New Haven, Connecticut, United States
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Coral Gables, Florida, United States
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Jacksonville, Florida, United States
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Margate, Florida, United States
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Douglasville, Georgia, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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West Lafayette, Indiana, United States
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Bowling Green, Kentucky, United States
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Rockville, Maryland, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Portsmouth, New Hampshire, United States
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New York, New York, United States
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Wilmington, North Carolina, United States
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Boardman, Ohio, United States
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Mason, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Mill Creek, Washington, United States
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Fredericton, New Brunswick, Canada
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Ajax, Ontario, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Rouen, Normandy, France
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Martigues, France
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Nantes, France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Heidelberg, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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München, Bavaria, Germany
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Blankenfelde-Mahlow, Brandenburg, Germany
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Darmstadt, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Bad Bentheim, Lower Saxony, Germany
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Münster, North Rhine Westfalia, Germany
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Dresden, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, Germany
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Hamburg, Germany
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Hamburg, Germany
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Debrecen, Hajdú-Bihar, Hungary
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Budapest, Hungary
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Szeged, Hungary
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Wroclaw, Lower Silesian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Sosnowiec, Silesian Voivodeship, Poland
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Szczecin, West Pomeranian Voivodeship, Poland
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Krakow, Woj. Małopolskie, Poland
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Lodz, Łódź Voivodeship, Poland
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Santiago de Compostela, A Coruña, Spain
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Badalona, Barcelona, Spain
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Las Palmas de Gran Canaria, Canary Islands, Spain
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Alicante, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Zaragoza, Spain
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Salford, Greater Manchester, United Kingdom
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Dudley, West Midlands, United Kingdom
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London, United Kingdom