This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA). Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
ENV-294 is an orally administered investigational capsule formulation. Participants receive 800 milligrams (mg) once daily by mouth for 12 weeks. Capsules are taken with water, at approximately the same time each day, with or without food.
Matching oral capsule that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Velocity Clinical Research - Medford
Medford, Oregon, United States
RECRUITINGIncidence and Severity of Adverse Events
Number and percentage of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug. Events will be summarized by severity and relationship to study treatment.
Time frame: From first dose through approximately 16 weeks
Change from baseline in hemaglobin.
Assessment of change from baseline in hemoglobin concentration to evaluate the safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study).
Observed values, change from baseline, and percent change from baseline in heart rate (beats per minute) as a measure of safety and tolerability of ENV-294.
Heart rate measured from 12-lead ECG recordings in beats per minute to assess cardiac safety and tolerability.
Time frame: Baseline through approximately 16 weeks (end of study).
Observed value, change from baseline, and percent change from baseline in systolic blood pressure (mmHg) as a measure of safety and tolerability.
Systolic blood pressure measured in millimeters of mercury (mmHg) using standard clinical procedures at each study visit to assess safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study).
Change from baseline in clinical chemistry laboratory values
Evaluation of changes from baseline in serum clinical chemistry values - including electrolytes (sodium, potassium, chloride), liver function tests (ALT, AST, alkaline phosphatase, bilirubin), kidney function tests (creatinine, blood urea nitrogen), and glucose - to assess the safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study).
Observed values and change from baseline in coagulation parameters as primary measures of safety and tolerability of ENV-294.
Coagulation tests include prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR). Changes from baseline will be assessed to evaluate safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study).
Observed values and change from baseline in urinalysis parameters as primary measures of safety and tolerability of ENV-294.
Urinalysis parameters include color, clarity, specific gravity, pH, protein, glucose, ketones, blood, leukocytes, and microscopic evaluation, as applicable. Changes from baseline will be evaluated to assess safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study).
Observed values, change from baseline, and percent change from baseline in RR interval (milliseconds) as a measure of safety and tolerability of ENV-294.
RR interval measured from 12-lead ECGs in milliseconds (ms) to assess cardiac safety and tolerability.
Time frame: Baseline through treatment and end of study (approximately Week 16).
Observed values, change from baseline, and percent change from baseline in PR interval (milliseconds) as a measure of safety and tolerability of ENV-294.
PR interval measured in milliseconds (ms) using standard 12-lead ECGs to assess safety and tolerability.
Time frame: Baseline through treatment and end of study (approximately Week 16).
Observed values, change from baseline, and percent change from baseline in QRS duration (milliseconds) as a measure of safety and tolerability of ENV-294.
QRS duration measured in milliseconds (ms) using standard 12-lead ECGs to assess cardiac conduction and safety.
Time frame: Baseline through treatment and end of study (approximately Week 16).
Observed values, change from baseline, and percent change from baseline in QT interval (milliseconds) as a measure of safety and tolerability of ENV-294.
QT interval measured in milliseconds (ms) using standard 12-lead ECGs to assess cardiac repolarization safety.
Time frame: Baseline through treatment and end of study (approximately Week 16).
Observed values, change from baseline, and percent change from baseline in QTc Bazett (milliseconds) as a measure of safety and tolerability of ENV-294.
QTc Bazett (QT corrected for heart rate using Bazett's formula) measured in milliseconds (ms) to evaluate cardiac safety.
Time frame: Baseline through treatment and end of study (approximately Week 16).
Observed values, change from baseline, and percent change from baseline in QTc Fridericia (milliseconds) as a measure of safety and tolerability of ENV-294.
QTc Fridericia (QT corrected for heart rate using Fridericia's formula) measured in milliseconds (ms) to evaluate cardiac safety.
Time frame: Baseline through treatment and end of study (approximately Week 16).
Observed value, change from baseline, and percent change from baseline in diastolic blood pressure (mmHg) as a measure of safety and tolerability.
Diastolic blood pressure measured in millimeters of mercury (mmHg) using standard clinical procedures at each study visit to assess safety and tolerability of ENV-294.
Time frame: Baseline through the treatment period and end of study at approximately week 16.
Observed value, change from baseline, and percent change from baseline in heart rate (beats per minute) as a measure of safety and tolerability.
Heart rate measured in beats per minute (bpm) using standard clinical procedures at each study visit to assess safety and tolerability of ENV-294.
Time frame: Baseline through the treatment priod and end of study at approximately week 16.
Observed value, change from baseline, and percent change from baseline in respiratory rate (breaths per minute) as a measure of safety and tolerability.
Respiratory rate measured in breaths per minute using standard clinical procedures at each study visit to assess safety and tolerability of ENV-294.
Time frame: Baseline through the treatment period and end of study at approximately week 16
Observed value, change from baseline, and percent change from baseline in body temperature (°F) as a measure of safety and tolerability.
Body temperature measured in degrees Fahrenheit using standard clinical procedures at each study visit to assess safety and tolerability of ENV-294.
Time frame: Baseline through the treatment period and the end of the study at approximately week 16
Change from baseline in hematocrit
Assessment of change from baseline in hematocrit value to evaluate the safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study)
Change from baseline in red blood cell count
Assessment of change from baseline in red blood cell (RBC) count to evaluate the safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study)
Change from baseline in white blood cell count with differential
Assessment of change from baseline in white blood cell (WBC) count with differential to evaluate the safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study)
Change from baseline in platelet count
Assessment of change from baseline in platelet count to evaluate the safety and tolerability of ENV-294.
Time frame: Baseline through approximately 16 weeks (end of study)
To assess the efficacy of ENV-294 in participants with asthma over a 12-week Treatment Period
Number and percentage of participants experiencing a loss of asthma control (LOAC) event during the treatment period, defined according to protocol-specified criteria (e.g., exacerbation requiring systemic corticosteroids, hospitalization, or significant decline in lung function).
Time frame: Treatment period through the end of the study at approximately 16 weeks
To assess the efficacy of ENV-294 in participants with asthma over a 12-week Treatment Period
Time from the first dose of study drug to the first occurrence of a loss of asthma control (LOAC) event, as defined in the protocol.
Time frame: From first treatment dose until the end of the study at approximately 16 weeks
To assess the efficacy of ENV-294 in participants with asthma over a 12-week Treatment Period
Change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁), measured using standardized spirometry.
Time frame: From baseline through the end of the study at approximately 16 weeks.
Plasma Cmax (maximum observed plasma concentration) of ENV-294
Plasma concentrations of ENV-294 will be measured at specified time points following oral administration to determine the maximum observed concentration (Cmax).
Time frame: At each scheduled PK collection time point during the 12-week treatment period
Plasma Tmax (time to reach maximum plasma concentration) of ENV-294
Time to reach maximum plasma concentration (Tmax) of ENV-294 will be determined from measured plasma concentrations following oral administration.
Time frame: At each scheduled pharmacokinetic (PK) collection time point during the 12-week treatment period
Plasma AUC (area under the concentration-time curve) of ENV-294
Area under the plasma concentration-time curve (AUC) for ENV-294 will be calculated from measured plasma concentrations to assess overall drug exposure.
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Time frame: At each scheduled pharmacokinetic (PK) collection time point during the 12-week treatment period