Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
Lead Sponsor:
Apogee Therapeutics, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06920901
Start Date
March 27 2025
End Date
March 1 2027
Last Update
September 9 2025
Active Locations (11)
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1
Investigational Site
La Jolla, California, United States, 92037
2
Investigational Site
Long Beach, California, United States, 90808
3
Investigational Site
San Jose, California, United States, 95117
4
Investigational Site
Torrance, California, United States, 90505