A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
Apogee Therapeutics, Inc.
350 participants
May 14, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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 in the Parent Study through 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
APG777 subcutaneous injection
APG777 subcutaneous injection every 12 weeks
APG777 subcutaneous injection every 24 weeks
Locations(42)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07003425