RecruitingPhase 2NCT07301255

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


Sponsor

Enveda Therapeutics

Enrollment

50 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This 12-week study is testing a new drug called ENV-294 for adults with moderate-to-severe asthma that is not fully controlled despite using standard inhalers (a combination of a steroid and a long-acting bronchodilator). Researchers want to see if this new treatment can improve breathing and reduce asthma symptoms. **You may be eligible if...** - You are between 18 and 75 years old - You have had a doctor's diagnosis of moderate-to-severe asthma for at least 12 months - You have been on a stable dose of an inhaled steroid plus a long-acting bronchodilator for at least 2 months - Your breathing tests (lung function) show a specific pattern of reduced airflow that improves with a rescue inhaler **You may NOT be eligible if...** - You smoke or have smoked heavily in the past - You have other serious lung conditions (like COPD) - You have had a severe asthma attack requiring hospitalization recently - You are pregnant or breastfeeding - You have serious heart, liver, or immune system conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGENV-294

ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.

DRUGPlacebo

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

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NCT07301255


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