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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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Participants will be randomized to APG777 + APG990 or dupilumab in a 1:1 ratio. Randomization will be stratified on Day 1 according to Baseline disease severity and geographic region.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APG777 + APG990

Participants will receive protocol specified combination dose of APG777 + APG990

Group Type EXPERIMENTAL

APG777

Intervention Type DRUG

Subcutaneous (SC) injection

APG990

Intervention Type DRUG

SC injection

Dupilumab

Participants will receive protocol specified dose of Dupilumab

Group Type ACTIVE_COMPARATOR

Dupilumab

Intervention Type DRUG

SC injection

Interventions

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APG777

Subcutaneous (SC) injection

Intervention Type DRUG

APG990

SC injection

Intervention Type DRUG

Dupilumab

SC injection

Intervention Type DRUG

Other Intervention Names

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Dupixent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apogee Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Site

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Investigational Site

Kogarah, New South Wales, Australia

Site Status RECRUITING

Investigational Site

Westmead, New South Wales, Australia

Site Status RECRUITING

Investigational Site

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Investigational Site

Carlton, Victoria, Australia

Site Status RECRUITING

Investigational Site

East Melbourne, Victoria, Australia

Site Status RECRUITING

Investigational Site

Mitcham, Victoria, Australia

Site Status RECRUITING

Investigational Site

Parkville, Victoria, Australia

Site Status RECRUITING

Investigational Site

Fremantle, Western Australia, Australia

Site Status RECRUITING

Investigational Site

London, Ontario, Canada

Site Status RECRUITING

Investigational Site

Peterborough, Ontario, Canada

Site Status RECRUITING

Investigational Site

Richmond Hill, Ontario, Canada

Site Status RECRUITING

Investigational Site

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site

Montreal, Quebec, Canada

Site Status RECRUITING

Investigational Site

Québec, Quebec, Canada

Site Status RECRUITING

Investigational Site

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Investigational Site

Hamilton, Waitako, New Zealand

Site Status RECRUITING

Investigational Site

Auckland, , New Zealand

Site Status RECRUITING

Countries

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Australia Canada New Zealand

Central Contacts

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Study Director

Role: CONTACT

+1 781 208 2408

Other Identifiers

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APG279-101

Identifier Type: -

Identifier Source: org_study_id

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