NCT07003425

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Apogee Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	APG777	APG777 subcutaneous injection
DRUG	APG777	APG777 subcutaneous injection every 12 weeks
DRUG	APG777	APG777 subcutaneous injection every 24 weeks

Timeline

• Start date: 2025-05-14
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-06-04
• Last updated: 2026-03-27

Locations

42 sites across 3 countries: United States, Canada, Poland

Regulatory

• FDA-regulated drug study