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

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.

Conditions

Asthma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

La Jolla

Orso Health, La Jolla, California, United States, 92037

San Jose

Allergy and Asthma Associates of Santa Clara Valley Research Center, San Jose, California, United States, 95117

Torrance

Orso Health, Torrance, California, United States, 90505

Kansas City

University of Kansas School of Medicine, Kansas City, Missouri, United States, 66160

Rochester

Rochester Regional Health, Rochester, New York, United States, 14607

Edmond

OK Clinical Research, LLC, Edmond, Oklahoma, United States, 73034

Philadelphia

Temple University, Philadelphia, Pennsylvania, United States, 19140

Pittsburgh

Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania, United States, 15241

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Apogee Therapeutics, Inc.,

Study Record Dates

2027-03