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RECRUITING Phase 2 ClinicalTrials.gov

A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

Sponsor: Apogee Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07003425

Registry updated: 2026-10-13
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Description

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.

Interventions

  • APG777 (Drug)
    APG777 subcutaneous injection
  • APG777 (Drug)
    APG777 subcutaneous injection every 12 weeks
  • APG777 (Drug)
    APG777 subcutaneous injection every 24 weeks

Eligibility criteria

Inclusion Criteria: * Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol * Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777 * Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study Exclusion Criteria: * Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient * Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study * Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study * Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments Note: Additional protocol defined Inclusion/Exclusion criteria may apply

Conditions

Atopic Dermatitis

Locations

  • Investigational Site — Fountain Valley, California, United States
  • Investigational Site — Los Angeles, California, 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 — Skokie, Illinois, 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 — 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 — Frisco, Texas, United States
  • Investigational Site — San Antonio, Texas, 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 — Fredericton, 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, Prague, Czechia
  • Investigational Site — Prague, Prague Motol, Czechia
  • Investigational Site — Prague, Vinohrady, Czechia
  • Investigational Site — Prague, Czechia
  • Investigational Site — Prague, Czechia
  • Investigational Site — Martigues, France
  • 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 — Berlin, Germany
  • Investigational Site — Hamburg, Germany
  • Investigational Site — Szeged, Csongrad-Csanad, Hungary
  • Investigational Site — Debrecen, Hajdú-Bihar, Hungary
  • Investigational Site — Budapest, 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, 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 — Madrid, Spain
  • Investigational Site — Salford, Greater Manchester, United Kingdom
  • Investigational Site — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record