NCT07301255

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Enveda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-09
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2025-12-24
• Last updated: 2026-03-31

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study