ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-03-27
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06920901

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening
  2. * Maintain FeNO-high (≥ 25 parts per billion \[ppb\]) or FeNO-low (\< 25 ppb) status from Screening to Day 1 prior to Randomization
  3. * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening
  4. * Asthma Control Test (ACT) score \> 19 at Screening
  5. * 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
  6. * Women of childbearing potential and male participants to use a highly effective form of contraception
  1. * 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
  2. * Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia
  3. * History of biologics use for treatment or control of asthma
  4. * Current smokers or participants with a smoking history of ≥ 10 pack years
  5. * Known history of illicit drug abuse, harmful alcohol use

Contacts and Locations

Study Locations (Sites)

Investigational Site
La Jolla, California, 92037
United States
Investigational Site
Long Beach, California, 90808
United States
Investigational Site
San Jose, California, 95117
United States
Investigational Site
Torrance, California, 90505
United States
Investigational Site
Normal, Illinois, 61761
United States
Investigational Site
Kansas City, Missouri, 66160
United States
Investigational Site
Edmond, Oklahoma, 73034
United States
Investigational Site
Philadelphia, Pennsylvania, 19140
United States
Investigational Site
Pittsburgh, Pennsylvania, 15241
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-03-27
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Asthma
  • Mild to moderate asthma
  • Tolerability
  • Immunogenicity
  • Pharmacokinetics

Additional Relevant MeSH Terms

  • Asthma