A Study Evaluating APG777 in Atopic Dermatitis

NCT06395948 · tracked via the Priya Life Science Germany tracker

Sponsor

Apogee Therapeutics, Inc

Phase

Phase 2

Started

2024-04-29

Last updated

2026-09-10

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

APG777 →Placebo

APG777: APG777 subcutaneous injection

Placebo: Matching placebo subcutaneous injection

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Have a diagnosis of AD that has been present for \>=1 year prior to the Screening visit * Moderate-to-severe AD at Screening and Baseline visits * History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable * Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for \>=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits. * Have completed itch questionnaires in the electronic diary for \>=4 of 7 days prior to Baseline visit Exclusion Criteria: * Participation in a prior study with APG777. * Prior treatment with protocol-specified monoclonal antibodies (mAbs) * Has used any AD-related topical medications within 7 days prior to Baseline visit. * Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit Note: Other protocol defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI) — Baseline and at Week 16
Part B: Proportion of participants who achieve EASI 75 at Week 16 — At Week 16

Trial sites (94)

Facility	City	Region
Investigational Site	Fountain Valley	California
Investigational Site	Los Angeles	California
Investigational Site	San Diego	California
Investigational Site	New Haven	Connecticut
Investigational Site	Coral Gables	Florida
Investigational Site	Jacksonville	Florida
Investigational Site	Margate	Florida
Investigational Site	Douglasville	Georgia
Investigational Site	Chicago	Illinois
Investigational Site	Skokie	Illinois
Investigational Site	West Lafayette	Indiana
Investigational Site	Bowling Green	Kentucky
Investigational Site	Rockville	Maryland
Investigational Site	Detroit	Michigan
Investigational Site	Troy	Michigan
Investigational Site	Portsmouth	New Hampshire
Investigational Site	New York	New York
Investigational Site	Wilmington	North Carolina
Investigational Site	Boardman	Ohio
Investigational Site	Mason	Ohio
Investigational Site	Portland	Oregon
Investigational Site	Pittsburgh	Pennsylvania
Investigational Site	Charleston	South Carolina
Investigational Site	Nashville	Tennessee
Investigational Site	Dallas	Texas
Investigational Site	Dallas	Texas
Investigational Site	San Antonio	Texas
Investigational Site	Norfolk	Virginia
Investigational Site	Mill Creek	Washington
Investigational Site	Calgary	Alberta
Investigational Site	Calgary	Alberta
Investigational Site	Edmonton	Alberta
Investigational Site	Vancouver	British Columbia
Investigational Site	Winnipeg	Manitoba
Investigational Site	Fredericton	New Brunswick
Investigational Site	Ajax	Ontario
Investigational Site	Markham	Ontario
Investigational Site	Mississauga	Ontario
Investigational Site	Ottawa	Ontario
Investigational Site	Peterborough	Ontario

+ 54 more sites — see the full list on the official registry below.

More Apogee Therapeutics, Inc. trials in Germany

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

Other trials for the same condition

A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

Microbiome in Atopic Dermatitis Under Systemic Therapy Recruiting

Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults Recruiting

A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC 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 NCT06395948 on ClinicalTrials.gov ↗ ← All trials in Germany