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A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
Sponsor: Apogee Therapeutics, Inc.
Summary
This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948). The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period. This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.
Official title: A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2025-05-14
Completion Date
2029-12
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
APG777
APG777 subcutaneous injection
APG777
APG777 subcutaneous injection every 12 weeks
APG777
APG777 subcutaneous injection every 24 weeks
Locations (42)
Investigational Site
Fountain Valley, California, United States
Investigational Site
Los Angeles, California, United States
Investigational Site
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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Skokie, Illinois, United States
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Bowling Green, Kentucky, United States
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Detroit, Michigan, United States
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Troy, Michigan, 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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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Frisco, Texas, United States
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San Antonio, Texas, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Fredericton, Brunswick, Canada
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Ajax, Ontario, Canada
Investigational Site
Markham, Ontario, Canada
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Mississauga, Ontario, Canada
Investigational Site
Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site
Lublin, Lublin Voivodeship, Poland
Investigational Site
Warsaw, Masovian Voivodeship, Poland
Investigational Site
Warsaw, Masovian Voivodeship, Poland
Investigational Site
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site
Katowice, Silesian Voivodeship, Poland
Investigational Site
Sosnowiec, Silesian Voivodeship, Poland
Investigational Site
Krakow, Woj. Małopolskie, Poland
Investigational Site
Lodz, Poland