Asthma
Conditions
Keywords
Asthma, Mild to moderate asthma, Tolerability, Immunogenicity, Pharmacokinetics
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.
Interventions
DRUGAPG777
APG777 subcutaneous injection
DRUGPlacebo
Matching placebo subcutaneous injection
Sponsors
Apogee Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Vital Signs | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) of APG777 | Up to 48 weeks |
| 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 |
Countries
United Kingdom, United States
Outcome results
None listed