A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
- Registration Number
- NCT06920901
- Lead Sponsor
- Apogee Therapeutics, Inc.
- 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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
Note: Other protocol defined criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APG777 APG777 Participants will receive protocol specified dose of APG7777 Placebo Placebo Participants will receive matching placebo
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events (TEAEs) Up to 52 weeks Number of Participants with Abnormal Laboratory Findings Up to 52 weeks Number of Participants with Abnormal Electrocardiograms (ECGs) Up to 52 weeks Number of Participants with Abnormal Physical Examination Findings Up to 52 weeks Number of Participants with Abnormal Vital Signs Up to 52 weeks
- Secondary Outcome Measures
Name Time Method Time to reach Cmax (tmax) Up to 48 weeks Terminal elimination rate constant (λz) Up to 48 weeks Terminal Elimination half-life (t1/2) Up to 48 weeks Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last) Up to 48 weeks AUC From Time 0 Extrapolated to Infinity (AUC0-inf) Up to 48 weeks Apparent Clearance of APG777 (CL/F) Up to 48 weeks Apparent Volume of Distribution (Vz/F) Up to 48 weeks Number of Participants with Anti-Drug-Antibodies (ADAs) Up to 48 weeks Cmax in Participants With and without ADAs Up to 48 weeks AUClast Participants With and without ADAs Up to 48 weeks AUCInf Participants With and without ADAs Up to 48 weeks Maximum concentration (Cmax) of APG777 Up to 48 weeks
Related Research Topics
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Trial Locations
- Locations (10)
Allergy and Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
University of Kansas School of Medicine
🇺🇸Kansas City, Missouri, United States
Sneeze, Wheeze & Itch Associates
🇺🇸Normal, Illinois, United States
Orso Health
🇺🇸Torrance, California, United States
Rochester Regional Health
🇺🇸Rochester, New York, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, West Yorkshire, United Kingdom
Medicines Evaluation Unit Ltd
🇬🇧Manchester, United Kingdom