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ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
Sponsor: Enveda Therapeutics
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-01-09
Completion Date
2027-01
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Placebo
Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Locations (14)
Enveda Investigative Site
Birmingham, Alabama, United States
Enveda Investigative Site
Los Angeles, California, United States
Enveda Investigative Site
San Jose, California, United States
Enveda Investigative Site
Colorado Springs, Colorado, United States
Enveda Investigative Site
Hialeah, Florida, United States
Enveda Investigative Site
Albany, Georgia, United States
Enveda Investigative Site
Owensboro, Kentucky, United States
Enveda Investigative Site
Southfield, Michigan, United States
Enveda Investigative Site
St Louis, Missouri, United States
Enveda Investigative Site
Clackamas, Oregon, United States
Enveda Investigative Site
Medford, Oregon, United States
Enveda Investigative Site
North Charleston, South Carolina, United States
Enveda Investigative Site
McKinney, Texas, United States
Enveda Investigative Site
Madison, Wisconsin, United States