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RECRUITING
NCT07301255
PHASE2

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults

Sponsor: Enveda Therapeutics

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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