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

NCT07027527 | Active Not Recruiting Phase 1

• 1 other identifier: APG279-101
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 20

Brief 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).

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Moderate-to-Severe AD; APG777; Dupilumab; APG990

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Up to 24 weeks

Secondary Outcomes (6)

• Predose Serum Concentrations (Ctrough) of APG777

  Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

• Predose Serum Concentrations (Ctrough) of APG990

  Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

• Maximum Serum Concentrations (Cmax) of APG777

  Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

• Maximum Serum Concentrations (Cmax) of APG990

  Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

• Time to Reach Cmax (tmax) of APG777

  Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

Study Arms (2)

APG777 + APG990

EXPERIMENTAL

Participants will receive protocol specified combination dose of APG777 + APG990

Drug: APG777; Drug: APG990

Dupilumab

ACTIVE COMPARATOR

Participants will receive protocol specified dose of Dupilumab

Drug: Dupilumab

Interventions

APG777 DRUG

Subcutaneous (SC) injection

APG777 + APG990

APG990 DRUG

SC injection

APG777 + APG990

Dupilumab DRUG

SC injection

Also known as: Dupixent

Dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Apogee Therapeutics, Inc.: lead

Study Sites (20)

Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Investigational Site

Kogarah, New South Wales, 2217, Australia

Location

Investigational Site

Westmead, New South Wales, 2145, Australia

Location

Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

Investigational Site

Carlton, Victoria, 3053, Australia

Location

Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

Investigational Site

Mitcham, Victoria, 3132, Australia

Location

Investigational Site

Parkville, Victoria, 3050, Australia

Location

Investigational Site

Fremantle, Western Australia, 6160, Australia

Location

Investigational Site

London, Ontario, N6H 5L5, Canada

Location

Investigational Site

Peterborough, Ontario, K9J 5K2, Canada

Location

Investigational Site

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Investigational Site

Toronto, Ontario, M4E 1R7, Canada

Location

Investigational Site

Toronto, Ontario, M4W 2N4, Canada

Location

Investigational Site

Toronto, Ontario, M5A 3R6, Canada

Location

Investigational Site

Montreal, Quebec, H1Y 3L1, Canada

Location

Investigational Site

Québec, Quebec, G1W 1S2, Canada

Location

Investigational Site

Sherbrooke, Quebec, J1G 1X9, Canada

Location

Investigational Site

Hamilton, Waitako, 3204, New Zealand

Location

Investigational Site

Auckland, 1051, New Zealand

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 18, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); CA (9); AU (9)