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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
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
ENV-294
ENV-294 is an orally administered investigational capsule formulation. Participants receive 800 milligrams (mg) once daily by mouth for 12 weeks. Capsules are taken with water, at approximately the same time each day, with or without food.
Placebo
Matching oral capsule that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Locations (14)
AllerVie Clinical Research
Birmingham, Alabama, United States
California Allergy and Asthma Medical
Los Angeles, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, United States
New Life Medical Research Center
Hialeah, Florida, United States
Georgia Pollens Clinical Research Centers
Albany, Georgia, United States
Allergy & Asthma Specialists
Owensboro, Kentucky, United States
Revive Research Institute
Southfield, Michigan, United States
The Clinical Research Center
St Louis, Missouri, United States
Portland Allergy & Asthma
Clackamas, Oregon, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Monroe Biomedical Research
North Charleston, South Carolina, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States