ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
Recruiting · NCT07301255 · Interventional (participants receive a specific treatment) · Lead sponsor: Enveda Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Able to read, understand, and sign an informed consent form before any study procedures
- Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
- Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
- Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
- Demonstrated bronchodilator reversibility
- ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline
- History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care
Exclusion criteria
- Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
- History of life-threatening asthma
- Other significant pulmonary disease
- Recent bronchial thermoplasty (within 2 years)
- Uncontrolled current or recurrent concomitant illness
- Recent use of biologic therapies for asthma (within 6 months or 5 half-lives)
- Require immunosuppressive medications or frequent systemic corticosteroids
- Current smokers or former smokers with significant smoking history
- Uncontrolled hypertension
- Significant hepatic impairment
Where it is running
18 locations listed across 14 US states.
- Enveda Investigative Site - Birmingham, Alabama, United States
- Enveda Investigative Site - Los Angeles, California, United States
- Enveda Investigative Site - San Jose, California, United States
- Enveda Investigative Site - West Hills, California, United States
- Enveda Investigative Site - Colorado Springs, Colorado, United States
- Enveda Investigative Site - Hialeah, Florida, United States
- Enveda Investigative Site - Miami, Florida, United States
- Enveda Investigative Site - Albany, Georgia, United States
- Enveda Investigative Site - Maryville, Illinois, United States
- Enveda Investigative Site - Kansas City, Kansas, United States
- Enveda Investigative Site - Owensboro, Kentucky, United States
- Enveda Investigative Site - Southfield, Michigan, United States
- Enveda Investigative Site - St Louis, Missouri, United States
- Enveda Investigative Site - Clackamas, Oregon, United States
- Enveda Investigative Site - Medford, Oregon, United States
- Enveda Investigative Site - North Charleston, South Carolina, United States
- Enveda Investigative Site - McKinney, Texas, United States
- Enveda Investigative Site - Madison, Wisconsin, United States