APG777 Safety and Tolerability in Mild-to-Moderate Asthma
APG777
+ Placebo
Asthma+6
+ Bronchial Diseases
+ Hypersensitivity
Treatment Study
Summary
Study start date: March 27, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating a new treatment called APG777 for adults who have mild-to-moderate asthma. The main goal is to understand how safe and tolerable this treatment is, as well as how the body processes it and how it might affect the immune system. Asthma can make breathing difficult, and finding effective treatments is important for improving the quality of life for those affected. This study aims to offer insights into a potential new treatment option that could help manage asthma symptoms more effectively. Participants in this study will be randomly assigned to receive either the APG777 treatment or a placebo, meaning some will receive the actual treatment and others will receive a non-active substitute. The study lasts about a year, with three main parts: screening, treatment, and follow-up. Throughout the study, researchers will closely monitor participants to gather data on safety and how the treatment interacts with the body. This approach helps ensure that any new treatment is both safe and effective for future use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Investigational Site
Long Beach, United StatesInvestigational Site
San Jose, United StatesInvestigational Site
Torrance, United States