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New treatment option for Asthma
Official title ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
ClinicalTrials.gov ID: NCT07301255
What this study is testing
What is ENV-294?
ENV-294 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Jose, California, United States
- Colorado Springs, Colorado, United States
- Hialeah, Florida, United States
- Albany, Georgia, United States
- Owensboro, Kentucky, United States
- Southfield, Michigan, United States
- St Louis, Missouri, United States
- Clackamas, Oregon, United States
- Medford, Oregon, United States
- North Charleston, South Carolina, United States
- McKinney, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; San Jose, California, United States; Colorado Springs, Colorado, United States; Hialeah, Florida, United States; Albany, Georgia, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.