Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
470 participants
INTERVENTIONAL
2024-04-29
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A: Induction Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
APG777
APG777 subcutaneous injection
Part A: Induction Period: Placebo
Participants will receive matching Placebo injections per protocol defined dosing regimen
Placebo
Matching placebo subcutaneous injection
Part A: Maintenance Period: APG777
Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
APG777
APG777 subcutaneous injection
Part B: Induction Period: APG777
Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
APG777
APG777 subcutaneous injection
Part B: Induction Period: Placebo
Participants will receive matching placebo injections per protocol defined dosing regimen
Placebo
Matching placebo subcutaneous injection
Part B: Maintenance Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
APG777
APG777 subcutaneous injection
Interventions
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APG777
APG777 subcutaneous injection
Placebo
Matching placebo subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Moderate-to-severe AD at Screening and Baseline visits
* History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
* Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for \>=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits.
* Have completed itch questionnaires in the electronic diary for \>=4 of 7 days prior to Baseline visit
Exclusion Criteria
* Prior treatment with protocol-specified monoclonal antibodies (mAbs)
* Has used any AD-related topical medications within 7 days prior to Baseline visit.
* Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit
18 Years
ALL
No
Sponsors
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Apogee Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Fountain Valley, California, United States
Investigational Site
Los Angeles, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
New Haven, Connecticut, United States
Investigational Site
Coral Gables, Florida, United States
Investigational Site
Jacksonville, Florida, United States
Investigational Site
Margate, Florida, United States
Investigational Site
Douglasville, Georgia, United States
Investigational Site
Chicago, Illinois, United States
Investigational Site
Skokie, Illinois, United States
Investigational Site
West Lafayette, Indiana, United States
Investigational Site
Bowling Green, Kentucky, United States
Investigational Site
Rockville, Maryland, United States
Investigational Site
Detroit, Michigan, United States
Investigational Site
Troy, Michigan, United States
Investigational Site
Portsmouth, New Hampshire, United States
Investigational Site
New York, New York, United States
Investigational Site
Wilmington, North Carolina, United States
Investigational Site
Boardman, Ohio, United States
Investigational Site
Mason, Ohio, United States
Investigational Site
Portland, Oregon, United States
Investigational Site
Pittsburgh, Pennsylvania, United States
Investigational Site
Charleston, South Carolina, United States
Investigational Site
Nashville, Tennessee, United States
Investigational Site
Dallas, Texas, United States
Investigational Site
Dallas, Texas, United States
Investigational Site
San Antonio, Texas, United States
Investigational Site
Norfolk, Virginia, United States
Investigational Site
Mill Creek, Washington, United States
Investigational Site
Calgary, Alberta, Canada
Investigational Site
Calgary, Alberta, Canada
Investigational Site
Edmonton, Alberta, Canada
Investigational Site
Vancouver, British Columbia, Canada
Investigational Site
Winnipeg, Manitoba, Canada
Investigational Site
Fredericton, New Brunswick, Canada
Investigational Site
Ajax, Ontario, Canada
Investigational Site
Markham, Ontario, Canada
Investigational Site
Mississauga, Ontario, Canada
Investigational Site
Ottawa, Ontario, Canada
Investigational Site
Peterborough, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Montreal, Quebec, Canada
Investigational Site
Québec, Quebec, Canada
Investigational Site
Prague, , Czechia
Investigational Site
Prague, , Czechia
Investigational Site
Prague, , Czechia
Investigational Site
Prague, , Czechia
Investigational Site
Prague, , Czechia
Investigational Site
Rouen, Normandy, France
Investigational Site
Martigues, , France
Investigational Site
Nantes, , France
Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
Investigational Site
Tübingen, Baden-Wurttemberg, Germany
Investigational Site
Augsburg, Bavaria, Germany
Investigational Site
München, Bavaria, Germany
Investigational Site
Blankenfelde-Mahlow, Brandenburg, Germany
Investigational Site
Darmstadt, Hesse, Germany
Investigational Site
Frankfurt am Main, Hesse, Germany
Investigational Site
Bad Bentheim, Lower Saxony, Germany
Investigational Site
Münster, North Rhine Westfalia, Germany
Investigational Site
Dresden, Saxony, Germany
Investigational Site
Kiel, Schleswig-Holstein, Germany
Investigational Site
Lübeck, Schleswig-Holstein, Germany
Investigational Site
Berlin, , Germany
Investigational Site
Hamburg, , Germany
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Hamburg, , Germany
Investigational Site
Debrecen, Hajdú-Bihar, Hungary
Investigational Site
Budapest, , Hungary
Investigational Site
Szeged, , Hungary
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
Szczecin, West Pomeranian Voivodeship, Poland
Investigational Site
Krakow, Woj. Małopolskie, Poland
Investigational Site
Lodz, Łódź Voivodeship, Poland
Investigational Site
Santiago de Compostela, A Coruña, Spain
Investigational Site
Badalona, Barcelona, Spain
Investigational Site
Las Palmas de Gran Canaria, Canary Islands, Spain
Investigational Site
Alicante, , Spain
Investigational Site
Barcelona, , Spain
Investigational Site
Madrid, , Spain
Investigational Site
Madrid, , Spain
Investigational Site
Zaragoza, , Spain
Investigational Site
Salford, Greater Manchester, United Kingdom
Investigational Site
Dudley, West Midlands, United Kingdom
Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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APG777-201
Identifier Type: -
Identifier Source: org_study_id