NCT07027527Active, not recruitingPhase 1
An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 11 Jun 2025
- Start date
- 4 Jun 2025
- Primary completion date
- 29 Aug 2026
- Lead sponsor
- Apogee Therapeutics, Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07027527
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 86
- From 4 Jun 2025 to the primary completion date, 29 Aug 2026
- 18 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
Related publications
- A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers.Clin Transl Sci · 2025 · PMID 41422501
This page is information, not medical advice. Discuss any trial with your doctor.