Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06920901

Active Not RecruitingPhase 1

Sponsor: Apogee Therapeutics, Inc.

Conditions: Asthma

Interventions: APG777, Placebo

Countries: United States, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (11)
  • La Jolla, California, United States
  • Long Beach, California, United States
  • San Jose, California, United States
  • Torrance, California, United States
  • Normal, Illinois, United States
  • Kansas City, Missouri, United States
  • Edmond, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Bradford, West Yorkshire, United Kingdom
  • Manchester, United Kingdom