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An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
Sponsor: Apogee Therapeutics, Inc.
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2025-06-04
Completion Date
2027-12
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
APG777
Subcutaneous (SC) injection
APG990
SC injection
Dupilumab
SC injection
Locations (20)
Investigational Site
Darlinghurst, New South Wales, Australia
Investigational Site
Kogarah, New South Wales, Australia
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Westmead, New South Wales, Australia
Investigational Site
Woolloongabba, Queensland, Australia
Investigational Site
Carlton, Victoria, Australia
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East Melbourne, Victoria, Australia
Investigational Site
Mitcham, Victoria, Australia
Investigational Site
Parkville, Victoria, Australia
Investigational Site
Fremantle, Western Australia, Australia
Investigational Site
London, Ontario, Canada
Investigational Site
Peterborough, Ontario, Canada
Investigational Site
Richmond Hill, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Hamilton, Waitako, New Zealand
Investigational Site
Auckland, New Zealand