ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT07301255

Run by

Enveda Therapeutics

People needed

50

Starts

2026-01-09

Expected to finish

2027-01-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Enveda Investigative Site — Birmingham, Alabama, United States (enrolling)
• Enveda Investigative Site — Los Angeles, California, United States (enrolling)
• Enveda Investigative Site — San Jose, California, United States (enrolling)
• Enveda Investigative Site — West Hills, California, United States (enrolling)
• Enveda Investigative Site — Colorado Springs, Colorado, United States (enrolling)
• Enveda Investigative Site — Hialeah, Florida, United States (enrolling)
• Enveda Investigative Site — Miami, Florida, United States (enrolling)
• Enveda Investigative Site — Albany, Georgia, United States (enrolling)
• Enveda Investigative Site — Maryville, Illinois, United States (enrolling)
• Enveda Investigative Site — Kansas City, Kansas, United States (enrolling)
• Enveda Investigative Site — Owensboro, Kentucky, United States (enrolling)
• Enveda Investigative Site — Southfield, Michigan, United States (enrolling)
• Enveda Investigative Site — St Louis, Missouri, United States (enrolling)
• Enveda Investigative Site — Clackamas, Oregon, United States (enrolling)
• Enveda Investigative Site — Medford, Oregon, United States (enrolling)
• Enveda Investigative Site — North Charleston, South Carolina, United States (enrolling)
• Enveda Investigative Site — McKinney, Texas, United States (enrolling)
• Enveda Investigative Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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