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Clinical Trials in the USA / NCT06920901
Active, not recruiting Phase 1

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

NCT06920901 · tracked via the Priya Life Science USA tracker
Sponsor
Apogee Therapeutics, Inc.
Phase
Phase 1
Started
2025-03-27
Last updated
2026-02-17

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

APG777 →Placebo

APG777: APG777 subcutaneous injection

Placebo: Matching placebo subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Investigational Site La Jolla California
Investigational Site Long Beach California
Investigational Site San Jose California
Investigational Site Torrance California
Investigational Site Normal Illinois
Investigational Site Kansas City Missouri
Investigational Site Edmond Oklahoma
Investigational Site Philadelphia Pennsylvania
Investigational Site Pittsburgh Pennsylvania
Investigational Site Bradford West Yorkshire
Investigational Site Manchester United Kingdom

More Apogee Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06920901 on ClinicalTrials.gov ↗ ← All trials in the USA