ENV-294 for adults with moderate-to-severe asthma — 12-week oral treatment
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
This 12-week study will test whether taking oral ENV-294 once daily can help adults with moderate-to-severe asthma who are already using inhaled corticosteroids and a LABA.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Enveda Therapeutics Industry-sponsored |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT07301255 on ClinicalTrials.gov |
What this trial studies
Adults with physician-diagnosed moderate-to-severe asthma who are stable on an inhaled corticosteroid plus a long-acting beta2-agonist are screened and randomized to receive either oral ENV-294 or placebo once daily for 12 weeks after a screening period of up to 28 days. The trial monitors safety and tolerability, measures drug levels (pharmacokinetics) and biological effects (pharmacodynamics), and evaluates effects on lung function and asthma control. Key eligibility includes pre-bronchodilator FEV1 50–80% predicted, bronchodilator reversibility, ACQ-5 between 1.25 and 3.0, and a recent history of at least one exacerbation requiring systemic steroids or emergency care. Participants attend regular on-site visits at one of three Enveda sites for testing and follow-up in a randomized, placebo-controlled design.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with physician-diagnosed moderate-to-severe asthma on stable ICS+LABA therapy, pre-bronchodilator FEV1 50–80% predicted, bronchodilator reversibility, ACQ-5 1.25–3.0, and a history of at least one exacerbation in the past year.
Not a fit: People with recent (within 4 weeks) moderate or severe exacerbations, a history of life-threatening asthma, other significant pulmonary disease, recent bronchial thermoplasty, or uncontrolled comorbid illnesses are unlikely to qualify and may not benefit.
Why it matters
Potential benefit: If successful, ENV-294 could provide an additional oral treatment option that improves lung function and asthma control for people not fully controlled on ICS/LABA.
How similar studies have performed: Phase 2 testing of novel oral asthma agents is relatively uncommon; while inhaled and biologic therapies have shown benefit in moderate-to-severe asthma, oral small-molecule approaches like ENV-294 have limited published clinical success so far.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 13 other locations
- 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 — Colorado Springs, Colorado, United States (Recruiting)
- Enveda Investigative Site — Hialeah, Florida, United States (Recruiting)
- Enveda Investigative Site — Albany, Georgia, United States (Recruiting)
- Enveda Investigative Site — Owensboro, Kentucky, United States (Recruiting)
- Enveda Investigative Site — Southfield, Michigan, United States (Recruiting)
- Enveda Investigative Site — St Louis, Missouri, 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 (Not_yet_recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: env-294.clinicaltrials@enveda.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.