NCT06395948

A Study Evaluating APG777 in Atopic Dermatitis

A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Apogee Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	APG777	APG777 subcutaneous injection
DRUG	Placebo	Matching placebo subcutaneous injection

Timeline

• Start date: 2024-04-29
• Primary completion: 2026-11-01
• Completion: 2028-06-01
• First posted: 2024-05-02
• Last updated: 2025-12-17

Locations

94 sites across 9 countries: United States, Canada, Czechia, France, Germany, Hungary, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study