A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
Purpose
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.
Condition
- Asthma
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental APG777 |
Participants will receive protocol specified dose of APG7777 |
|
|
Placebo Comparator Placebo |
Participants will receive matching placebo |
|
Recruiting Locations
Orso Health
La Jolla, California 92037
La Jolla, California 92037
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California 95117
San Jose, California 95117
Orso Health
Torrance, California 90505
Torrance, California 90505
University of Kansas School of Medicine
Kansas City, Missouri 66160
Kansas City, Missouri 66160
OK Clinical Research, LLC
Edmond, Oklahoma 73034
Edmond, Oklahoma 73034
More Details
- NCT ID
- NCT06920901
- Status
- Recruiting
- Sponsor
- Apogee Therapeutics, Inc.