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Clinical Trials in Australia / NCT07027527
Active, not recruiting Phase 1

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

NCT07027527 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2025-06-04
Last updated
2026-09-08

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

APG777 →APG990Dupilumab →

APG777: Subcutaneous (SC) injection

APG990: SC injection

Dupilumab: SC injection

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Investigational Site Darlinghurst New South Wales
Investigational Site Kogarah New South Wales
Investigational Site Westmead New South Wales
Investigational Site Woolloongabba Queensland
Investigational Site Carlton Victoria
Investigational Site East Melbourne Victoria
Investigational Site Mitcham Victoria
Investigational Site Parkville Victoria
Investigational Site Fremantle Western Australia
Investigational Site London Ontario
Investigational Site Peterborough Ontario
Investigational Site Richmond Hill Ontario
Investigational Site Toronto Ontario
Investigational Site Toronto Ontario
Investigational Site Toronto Ontario
Investigational Site Montreal Quebec
Investigational Site Québec Quebec
Investigational Site Sherbrooke Quebec
Investigational Site Hamilton Waitako
Investigational Site Auckland New Zealand

On this site

📄 Dupixent (dupilumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07027527 on ClinicalTrials.gov ↗ ← All trials in Australia