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NCT Number: NCT06920901

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.

The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Bradford, West Yorkshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening
  • Maintain FeNO-high (≥ 25 parts per billion [ppb]) or FeNO-low (< 25 ppb) status from Screening to Day 1 prior to Randomization
  • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening
  • Asthma Control Test (ACT) score > 19 at Screening
  • Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose inhaled corticosteroids (ICS) or stable dose of ICS/ long-acting beta-agonist (LABA); +/- stable dose leukotriene receptor antagonist (LTRA). ICS dose should be stable for ≥ 12 weeks prior to Day 1, LTRA dose should be stable for ≥ 8 weeks prior to Day 1
  • Women of childbearing potential and male participants to use a highly effective form of contraception

Exclusion criteria

  • Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Screening and/or any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to Screening
  • Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia
  • History of biologics use for treatment or control of asthma
  • Current smokers or participants with a smoking history of ≥ 10 pack years
  • Known history of illicit drug abuse, harmful alcohol use

Note: Other protocol defined criteria may apply.

Treatment and study plan

APG777

Drug

APG777 subcutaneous injection

Placebo

Drug

Matching placebo subcutaneous injection

Primary outcomes

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

    Time frame: Up to 52 weeks

  2. Number of Participants with Abnormal Laboratory Findings

    Time frame: Up to 52 weeks

  3. Number of Participants with Abnormal Vital Signs

    Time frame: Up to 52 weeks

  4. Number of Participants with Abnormal Electrocardiograms (ECGs)

    Time frame: Up to 52 weeks

  5. Number of Participants with Abnormal Physical Examination Findings

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Maximum concentration (Cmax) of APG777

    Time frame: Up to 48 weeks

  2. Time to reach Cmax (tmax)

    Time frame: Up to 48 weeks

  3. Terminal elimination rate constant (λz)

    Time frame: Up to 48 weeks

  4. Terminal Elimination half-life (t1/2)

    Time frame: Up to 48 weeks

  5. Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)

    Time frame: Up to 48 weeks

  6. AUC From Time 0 Extrapolated to Infinity (AUC0-inf)

    Time frame: Up to 48 weeks

  7. Apparent Clearance of APG777 (CL/F)

    Time frame: Up to 48 weeks

  8. Apparent Volume of Distribution (Vz/F)

    Time frame: Up to 48 weeks

  9. Number of Participants with Anti-Drug-Antibodies (ADAs)

    Time frame: Up to 48 weeks

  10. Cmax in Participants With and without ADAs

    Time frame: Up to 48 weeks

  11. AUClast Participants With and without ADAs

    Time frame: Up to 48 weeks

  12. AUCInf Participants With and without ADAs

    Time frame: Up to 48 weeks

Sponsors and collaborators

Lead sponsor

Apogee Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
Feb 17, 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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