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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• 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, 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

+ 51 more sites.

Who to contact

Study Director · 7812082408 · ClinicalTrials@apogeetherapeutics.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07003425.