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Clinical Trials in Spain / NCT06395948
Active, not recruiting Phase 2

A Study Evaluating APG777 in Atopic Dermatitis

NCT06395948 · tracked via the Priya Life Science Spain tracker
Sponsor
Apogee Therapeutics, Inc
Phase
Phase 2
Started
2024-04-29
Last updated
2026-10-06

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
No
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)

FacilityCityRegionStatus
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 Spain

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

Other trials for the same condition

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting
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 Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis Recruiting
A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis 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 Spain