A Study Evaluating APG777 in Atopic Dermatitis

Launched by APOGEE THERAPEUTICS, INC. · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called APG777 for people with moderate-to-severe Atopic Dermatitis (AD), which is a skin condition that causes itchy and inflamed skin. The study is divided into two parts. In Part A, participants will receive one dose of APG777 or a placebo (a substance with no active medication) to see how safe and effective it is. They will also test two different ways to maintain treatment. In Part B, the study will compare three different doses of APG777 to a placebo to understand the benefits and risks. Overall, each participant may be involved in the study for up to 106 weeks, which includes screening, treatment, and follow-up.

To be eligible for this study, participants must have had AD for at least a year and have moderate-to-severe symptoms that haven't responded well to other treatments. They should have been using a stable over-the-counter moisturizer for at least 14 days before joining the study and have kept a record of their itch levels. Participants cannot have taken certain medications or been part of other studies with APG777 before. Throughout the trial, participants can expect regular visits to the clinic for assessments and check-ups. This study is currently recruiting participants of all genders aged 18 and older.

Gender

ALL

Eligibility 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.