NCT07301255RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 9 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Enveda Therapeutics
- Diseases
- Asthma
- NCT number
- NCT07301255
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 9 Jan 2026 to the primary completion date, 31 Dec 2026
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
- 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
Other illness
- History of life-threatening asthma
- Other significant pulmonary disease
- Uncontrolled hypertension
- Significant hepatic impairment
Other
- Recent bronchial thermoplasty (within 2 years)
- Current smokers or former smokers with significant smoking history
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Enveda Investigative Site Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Maryville | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | McKinney | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Medford | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | North Charleston | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Owensboro | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | San Jose | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | Southfield | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Enveda Investigative Site Coordinator of this site? Confirm its status | West Hills | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.