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

February 12, 2026 updated by: Apogee Therapeutics, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • Investigational Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Investigational Site
      • Long Beach, California, United States, 90808
        • Investigational Site
      • San Jose, California, United States, 95117
        • Investigational Site
      • Torrance, California, United States, 90505
        • Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 66160
        • Investigational Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive matching placebo
Drug: Placebo
Matching placebo subcutaneous injection
Experimental: APG777
Participants will receive protocol specified dose of APG7777
Drug: APG777
APG777 subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants with Abnormal Laboratory Findings
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants with Abnormal Vital Signs
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants with Abnormal Electrocardiograms (ECGs)
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants with Abnormal Physical Examination Findings
Time Frame: Up to 52 weeks
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax) of APG777
Time Frame: Up to 48 weeks
Up to 48 weeks
Time to reach Cmax (tmax)
Time Frame: Up to 48 weeks
Up to 48 weeks
Terminal elimination rate constant (λz)
Time Frame: Up to 48 weeks
Up to 48 weeks
Terminal Elimination half-life (t1/2)
Time Frame: Up to 48 weeks
Up to 48 weeks
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
Up to 48 weeks
AUC From Time 0 Extrapolated to Infinity (AUC0-inf)
Time Frame: Up to 48 weeks
Up to 48 weeks
Apparent Clearance of APG777 (CL/F)
Time Frame: Up to 48 weeks
Up to 48 weeks
Apparent Volume of Distribution (Vz/F)
Time Frame: Up to 48 weeks
Up to 48 weeks
Number of Participants with Anti-Drug-Antibodies (ADAs)
Time Frame: Up to 48 weeks
Up to 48 weeks
Cmax in Participants With and without ADAs
Time Frame: Up to 48 weeks
Up to 48 weeks
AUClast Participants With and without ADAs
Time Frame: Up to 48 weeks
Up to 48 weeks
AUCInf Participants With and without ADAs
Time Frame: Up to 48 weeks
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apogee Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APG777-105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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