An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis

Launched by APOGEE THERAPEUTICS, INC. · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and how the body processes a new combination of medicines called APG777 and APG990 for adults with moderate-to-severe atopic dermatitis, a common skin condition that causes itchy, inflamed skin. The study will compare this new treatment to an existing medicine called dupilumab to see how well it is tolerated and if it is safe to use. Each person who joins the study will take part for about 82 weeks, which includes a time for initial testing, 24 weeks of treatment, and follow-up visits afterward.

To be eligible, participants need to be adults with moderate-to-severe atopic dermatitis that has lasted for at least a year and has not improved enough with usual skin treatments. The condition must cover at least 10% of their body and meet certain severity scores checked by the doctor. Women who can become pregnant will need to have pregnancy tests before starting the study. People who have used similar treatments recently or have certain other skin problems won’t be able to join. Participants can expect regular visits to the study center for tests and monitoring throughout the study to make sure the treatment is working well and to check for any side effects. This study is currently recruiting adults of all genders who meet these criteria.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Have a diagnosis of AD that has been present for ≥ 1 year prior to the Screening visit and as determined by the Investigator through participant interview and/or review of the medical history.
• • Moderate-to-severe AD at Screening and Baseline (Day 1) visits, defined as: a) Eczema Area and Severity Index (EASI) score of ≥ 16, b) vIGA-AD score of ≥ 3, and c) AD affecting ≥10% of body surface area (BSA).
• • History of inadequate response to treatment with topical medications
• • Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit.
• • Exclusion Criteria
• • Participation in a prior study with APG777 or APG990.
• • 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
• • History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab.
• • Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments
• • Note: Additional protocol defined Inclusion/Exclusion criteria apply