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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Australia
Investigational Site
RECRUITING
Carlton
Investigational Site
RECRUITING
Darlinghurst
Investigational Site
RECRUITING
East Melbourne
Investigational Site
RECRUITING
Fremantle
Investigational Site
RECRUITING
Kogarah
Investigational Site
RECRUITING
Mitcham
Investigational Site
NOT_YET_RECRUITING
Parkville
Investigational Site
RECRUITING
Westmead
Investigational Site
RECRUITING
Woolloongabba
Canada
Investigational Site
NOT_YET_RECRUITING
Calgary
Investigational Site
RECRUITING
London
Investigational Site
RECRUITING
Montreal
Investigational Site
NOT_YET_RECRUITING
Peterborough
Investigational Site
RECRUITING
Québec
Investigational Site
RECRUITING
Richmond Hill
Investigational Site
RECRUITING
Sherbrooke
Investigational Site
RECRUITING
Toronto
Investigational Site
RECRUITING
Toronto
Investigational Site
NOT_YET_RECRUITING
Toronto
New Zealand
Investigational Site
RECRUITING
Auckland
Investigational Site
RECRUITING
Hamilton
Contact Information
Primary
Study Director
ClinicalTrials@apogeetherapeutics.com
+1 781 208 2408
Time Frame
Start Date:2025-06-04
Estimated Completion Date:2027-10
Participants
Target number of participants:50
Treatments
Experimental: APG777 + APG990
Participants will receive protocol specified combination dose of APG777 + APG990
Active_comparator: Dupilumab
Participants will receive protocol specified dose of Dupilumab