A Study Evaluating APG777 in Atopic Dermatitis

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by April W. Armstrong, MD, MPH
Headshot of April W. Armstrong
April W. Armstrong

Description

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.

Official Title

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

Keywords

Atopic Dermatitis, APG777, Safety, Efficacy, Dermatitis, Eczema

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • Investigational Site # 46 accepting new patients
    Los Angeles California 90024 United States
  • Investigational Site #14 accepting new patients
    Fountain Valley California 92708 United States

Lead Scientist at UCLA

  • April W. Armstrong, MD, MPH
    Dr. April Armstrong is Professor and Chief of Dermatology at University of California Los Angeles (UCLA). She oversees and leads the dermatology division, including managing clinical operations and promoting research and education. She also serves as Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Apogee Therapeutics, Inc.
Links
Sign up for this study
ID
NCT06395948
Phase
Phase 2 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 391 study participants
Last Updated
Contact us about this trial