A Study Evaluating APG777 in Atopic Dermatitis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT06395948

Run by

Apogee Therapeutics, Inc.

People needed

470

Starts

2024-04-29

Expected to finish

2028-06-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site — Los Angeles, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — New Haven, Connecticut, United States
• Investigational Site — Coral Gables, Florida, United States
• Investigational Site — Jacksonville, Florida, United States
• Investigational Site — Margate, Florida, United States
• Investigational Site — Douglasville, Georgia, United States
• Investigational Site — Chicago, Illinois, United States
• Investigational Site — Skokie, Illinois, United States
• Investigational Site — West Lafayette, Indiana, United States
• Investigational Site — Bowling Green, Kentucky, United States
• Investigational Site — Rockville, Maryland, United States
• Investigational Site — Detroit, Michigan, United States
• Investigational Site — Troy, Michigan, United States
• Investigational Site — Portsmouth, New Hampshire, United States
• Investigational Site — New York, New York, United States
• Investigational Site — Wilmington, North Carolina, United States
• Investigational Site — Boardman, Ohio, United States
• Investigational Site — Mason, Ohio, United States
• Investigational Site — Portland, Oregon, United States
• Investigational Site — Pittsburgh, Pennsylvania, United States
• Investigational Site — Charleston, South Carolina, United States
• Investigational Site — Nashville, Tennessee, United States
• Investigational Site — Dallas, Texas, United States
• Investigational Site — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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