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

NCT07003425 · tracked via the Priya Life Science UK tracker

Sponsor

Apogee Therapeutics, Inc.

Phase

Phase 2

Started

2025-05-14

Last updated

2026-09-08

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

APG777APG777APG777

APG777: APG777 subcutaneous injection

APG777: APG777 subcutaneous injection every 12 weeks

APG777: APG777 subcutaneous injection every 24 weeks

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Number of Participants with Treatment Emergent Adverse Events — Up to 3 years

Trial sites (71)

Facility	City	Region	Status
Investigational Site	Fountain Valley	California	Recruiting
Investigational Site	Los Angeles	California	Recruiting
Investigational Site	Coral Gables	Florida	Recruiting
Investigational Site	Jacksonville	Florida	Recruiting
Investigational Site	Margate	Florida	Recruiting
Investigational Site	Douglasville	Georgia	Recruiting
Investigational Site	Skokie	Illinois	Recruiting
Investigational Site	Bowling Green	Kentucky	Recruiting
Investigational Site	Rockville	Maryland	Recruiting
Investigational Site	Detroit	Michigan	Recruiting
Investigational Site	Troy	Michigan	Recruiting
Investigational Site	New York	New York	Recruiting
Investigational Site	Wilmington	North Carolina	Recruiting
Investigational Site	Boardman	Ohio	Recruiting
Investigational Site	Mason	Ohio	Recruiting
Investigational Site	Portland	Oregon	Recruiting
Investigational Site	Pittsburgh	Pennsylvania	Recruiting
Investigational Site	Charleston	South Carolina	Recruiting
Investigational Site	Nashville	Tennessee	Recruiting
Investigational Site	Dallas	Texas	Recruiting
Investigational Site	Frisco	Texas	Recruiting
Investigational Site	San Antonio	Texas	Recruiting
Investigational Site	Mill Creek	Washington	Recruiting
Investigational Site	Calgary	Alberta	Recruiting
Investigational Site	Calgary	Alberta	Recruiting
Investigational Site	Edmonton	Alberta	Recruiting
Investigational Site	Vancouver	British Columbia	Recruiting
Investigational Site	Fredericton	Brunswick	Recruiting
Investigational Site	Ajax	Ontario	Recruiting
Investigational Site	Markham	Ontario	Recruiting
Investigational Site	Mississauga	Ontario	Recruiting
Investigational Site	Ottawa	Ontario	Recruiting
Investigational Site	Peterborough	Ontario	Recruiting
Investigational Site	Toronto	Ontario	Recruiting
Investigational Site	Toronto	Ontario	Recruiting
Investigational Site	Toronto	Ontario	Recruiting
Investigational Site	Montreal	Quebec	Recruiting
Investigational Site	Québec	Quebec	Recruiting
Investigational Site	Prague	Prague	Recruiting
Investigational Site	Prague	Prague Motol	Recruiting

+ 31 more sites — see the full list on the official registry below.

More Apogee Therapeutics, Inc. trials in the UK

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma Active, not recruiting

A Study Evaluating APG777 in Atopic Dermatitis Active, not recruiting

Other trials for the same condition

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis Recruiting

A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants. Recruiting

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Recruiting

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD) Active, not recruiting

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07003425 on ClinicalTrials.gov ↗ ← All trials in the UK