Actively Recruiting
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
Led by Enveda Therapeutics · Updated on 2026-04-23
50
Participants Needed
14
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 651.25 to 6543.0 at screening and baseline
- History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Enveda Investigative Site
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Enveda Investigative Site
Los Angeles, California, United States, 90025
Actively Recruiting
3
Enveda Investigative Site
San Jose, California, United States, 95117
Actively Recruiting
4
Enveda Investigative Site
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
5
Enveda Investigative Site
Hialeah, Florida, United States, 33012
Actively Recruiting
6
Enveda Investigative Site
Albany, Georgia, United States, 31707
Actively Recruiting
7
Enveda Investigative Site
Owensboro, Kentucky, United States, 42301
Actively Recruiting
8
Enveda Investigative Site
Southfield, Michigan, United States, 48075
Actively Recruiting
9
Enveda Investigative Site
St Louis, Missouri, United States, 63141
Actively Recruiting
10
Enveda Investigative Site
Clackamas, Oregon, United States, 97015
Actively Recruiting
11
Enveda Investigative Site
Medford, Oregon, United States, 97504
Actively Recruiting
12
Enveda Investigative Site
North Charleston, South Carolina, United States, 29406
Actively Recruiting
13
Enveda Investigative Site
McKinney, Texas, United States, 75069
Actively Recruiting
14
Enveda Investigative Site
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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