A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Investigational Site
RECRUITING
Fountain Valley
Florida
Investigational Site
RECRUITING
Coral Gables
Investigational Site
RECRUITING
Margate
Michigan
Investigational Site
NOT_YET_RECRUITING
Detroit
Investigational Site
RECRUITING
Troy
North Carolina
Investigational Site
NOT_YET_RECRUITING
Wilmington
Ohio
Investigational Site
NOT_YET_RECRUITING
Boardman
Investigational Site
RECRUITING
Mason
Oregon
Investigational Site
NOT_YET_RECRUITING
Portland
Tennessee
Investigational Site
RECRUITING
Nashville
Texas
Investigational Site
NOT_YET_RECRUITING
Frisco
Investigational Site
RECRUITING
San Antonio
Other Locations
Canada
Investigational Site
NOT_YET_RECRUITING
Calgary
Investigational Site
NOT_YET_RECRUITING
Edmonton
Investigational Site
RECRUITING
Fredericton
Investigational Site
RECRUITING
Markham
Investigational Site
RECRUITING
Mississauga
Investigational Site
RECRUITING
Montreal
Investigational Site
RECRUITING
Peterborough
Investigational Site
RECRUITING
Québec
Investigational Site
RECRUITING
Toronto
Investigational Site
RECRUITING
Toronto
Investigational Site
NOT_YET_RECRUITING
Toronto
Poland
Investigational Site
NOT_YET_RECRUITING
Gdansk
Investigational Site
NOT_YET_RECRUITING
Katowice
Investigational Site
NOT_YET_RECRUITING
Krakow
Investigational Site
NOT_YET_RECRUITING
Lodz
Investigational Site
NOT_YET_RECRUITING
Lublin
Investigational Site
NOT_YET_RECRUITING
Sosnowiec
Investigational Site
NOT_YET_RECRUITING
Warsaw
Investigational Site
NOT_YET_RECRUITING
Wroclaw
Investigational Site
NOT_YET_RECRUITING
Wroclaw
Contact Information
Primary
Study Director
ClinicalTrials@apogeetherapeutics.com
7812082408
Time Frame
Start Date:2025-05-14
Estimated Completion Date:2029-12
Participants
Target number of participants:350
Treatments
Experimental: APG777 - Long Term Extension Treatment - 12 Weeks
Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
Experimental: APG777 - Long Term Extension Treatment - 24 Weeks
Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
Experimental: APG777 - Open Label Escape Arm
Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.