An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT07027527
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2025-06-04
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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APG777 + APG990
Participants will receive protocol specified combination dose of APG777 + APG990
APG777
Subcutaneous (SC) injection
APG990
SC injection
Dupilumab
Participants will receive protocol specified dose of Dupilumab
Dupilumab
SC injection
Interventions
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APG777
Subcutaneous (SC) injection
APG990
SC injection
Dupilumab
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Apogee Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Darlinghurst, New South Wales, Australia
Investigational Site
Kogarah, New South Wales, Australia
Investigational Site
Westmead, New South Wales, Australia
Investigational Site
Woolloongabba, Queensland, Australia
Investigational Site
Carlton, Victoria, Australia
Investigational Site
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
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Toronto, Ontario, Canada
Investigational Site
Montreal, Quebec, Canada
Investigational Site
Québec, Quebec, Canada
Investigational Site
Sherbrooke, Quebec, Canada
Investigational Site
Hamilton, Waitako, New Zealand
Investigational Site
Auckland, , New Zealand
Countries
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Central Contacts
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Other Identifiers
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APG279-101
Identifier Type: -
Identifier Source: org_study_id
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