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Evaluating APG777 for treating 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

Phase 2 Interventional Apogee Therapeutics, Inc. · NCT06395948

This study is testing a new treatment called APG777 to see if it can help people with moderate-to-severe Atopic Dermatitis feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment391 (estimated)
Ages18 Years and up
SexAll
SponsorApogee Therapeutics, Inc. Industry-sponsored
Locations64 sites (Fountain Valley, California and 63 other locations)
Trial IDNCT06395948 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety and efficacy of APG777 in individuals with moderate-to-severe Atopic Dermatitis (AD). It consists of two parts: Part A focuses on proof-of-concept, while Part B aims to determine the optimal dosing regimen. Participants will be randomized to receive either APG777 or a placebo, with the study lasting up to 106 weeks, including screening, treatment, and follow-up phases. The trial will evaluate various dose regimens to find the most effective treatment for AD.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with moderate-to-severe Atopic Dermatitis who have not responded adequately to topical treatments.

Not a fit: Patients who have previously participated in studies involving APG777 or have used certain AD-related treatments recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from moderate-to-severe Atopic Dermatitis.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in developing new treatments for Atopic Dermatitis.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fountain Valley, California and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisAPG777SafetyEfficacy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.