A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
NCT07003425 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2026-05-15
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
Interventions
- DRUG
-
APG777
APG777 subcutaneous injection
- DRUG
-
APG777
APG777 subcutaneous injection every 12 weeks
- DRUG
-
APG777
APG777 subcutaneous injection every 24 weeks
Sponsors & Collaborators
-
Apogee Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-14
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
Countries
- United States
- Canada
- Germany
- Poland
Study Locations
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