ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Asthma
- Asthma
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Enveda Therapeutics
- Enrolment target
- 50
- Started
- 9 January 2026
- Main results due
- December 2026
- Study sites
- 20
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(20)
Enveda Investigative Site
Birmingham, Alabama, United States
Recruiting
Enveda Investigative Site
Los Angeles, California, United States
Recruiting
Enveda Investigative Site
San Jose, California, United States
Recruiting
Enveda Investigative Site
West Hills, California, United States
Recruiting
Enveda Investigative Site
Colorado Springs, Colorado, United States
Recruiting
Enveda Investigative Site
Hialeah, Florida, United States
Recruiting
Enveda Investigative Site
Miami, Florida, United States
Recruiting
Enveda Investigative Site
Albany, Georgia, United States
Recruiting
Enveda Investigative Site
Maryville, Illinois, United States
Recruiting
Enveda Investigative Site
Kansas City, Kansas, United States
Recruiting
Enveda Investigative Site
Owensboro, Kentucky, United States
Recruiting
Enveda Investigative Site
Boston, Massachusetts, United States
Recruiting
Enveda Investigative Site
Southfield, Michigan, United States
Recruiting
Enveda Investigative Site
St Louis, Missouri, United States
Recruiting
Enveda Investigative Site
The Bronx, New York, United States
Recruiting
Enveda Investigative Site
Clackamas, Oregon, United States
Recruiting
Enveda Investigative Site
Medford, Oregon, United States
Recruiting
Enveda Investigative Site
North Charleston, South Carolina, United States
Recruiting
Enveda Investigative Site
McKinney, Texas, United States
Recruiting
Enveda Investigative Site
Madison, Wisconsin, United States
Recruiting
Showing 20 of 20 sites. 20 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07301255. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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