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NCT Number: NCT07027527

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Darlinghurst, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Note: Additional protocol defined Inclusion/Exclusion criteria apply

Treatment and study plan

APG777

Drug

Subcutaneous (SC) injection

APG990

Drug

SC injection

Dupilumab

Drug

SC injection

Other names: Dupixent

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Predose Serum Concentrations (Ctrough) of APG777

    Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

    PK parameters will be performed using a non-compartmental approach with a validated PK software.

  2. Predose Serum Concentrations (Ctrough) of APG990

    Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

    PK parameters will be performed using a non-compartmental approach with a validated PK software.

  3. Maximum Serum Concentrations (Cmax) of APG777

    Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

    PK parameters will be performed using a non-compartmental approach with a validated PK software

  4. Maximum Serum Concentrations (Cmax) of APG990

    Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

    PK parameters will be performed using a non-compartmental approach with a validated PK software.

  5. Time to Reach Cmax (tmax) of APG777

    Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

    PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.

  6. Time to Reach Cmax (tmax) of APG990

    Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24

    PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.

Sponsors and collaborators

Lead sponsor

Apogee Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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