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

NCT07301255 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ENV-294-211
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 14

Brief 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

Keywords

Asthma in Adults

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events

  Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.

  From first dose through approximately 16 weeks

Secondary Outcomes (6)

• Loss of Asthma Control Events

  Baseline to Week 12

• Time to Loss of Asthma Control

  Baseline to Week 12

• To assess the efficacy of ENV-294 in participants with asthma

  Baseline to Week 12

• To assess the efficacy of ENV-294 in participants with asthma

  Baseline to Week 12

• To assess the efficacy of ENV-294 in participants with asthma

  Baseline to Week 12

Study Arms (2)

ENV-294 Treatment Arm

EXPERIMENTAL

ENV-294 will be administered to those participants randomized to the treatment arm.

Drug: ENV-294

Placebo Arm

PLACEBO COMPARATOR

A placebo will be administered to those participants randomized to the placebo arm.

Drug: Placebo

Interventions

ENV-294 DRUG

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

ENV-294 Treatment Arm

Placebo DRUG

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.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read, understand, and sign an informed consent form before any study procedures
• Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
• Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
• Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
• Demonstrated bronchodilator reversibility
• ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline
• History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care

You may not qualify if:

• Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
• History of life-threatening asthma
• Other significant pulmonary disease
• Recent bronchial thermoplasty (within 2 years)
• Uncontrolled current or recurrent concomitant illness
• Recent use of biologic therapies for asthma (within 6 months or 5 half-lives)
• Require immunosuppressive medications or frequent systemic corticosteroids
• Current smokers or former smokers with significant smoking history
• Uncontrolled hypertension
• Significant hepatic impairment

Sponsors & Collaborators

• Enveda Therapeutics: lead

Study Sites (14)

Enveda Investigative Site

Birmingham, Alabama, 35209, United States

RECRUITING

Enveda Investigative Site

Los Angeles, California, 90025, United States

RECRUITING

Enveda Investigative Site

San Jose, California, 95117, United States

RECRUITING

Enveda Investigative Site

Colorado Springs, Colorado, 80907, United States

RECRUITING

Enveda Investigative Site

Hialeah, Florida, 33012, United States

RECRUITING

Enveda Investigative Site

Albany, Georgia, 31707, United States

RECRUITING

Enveda Investigative Site

Owensboro, Kentucky, 42301, United States

RECRUITING

Enveda Investigative Site

Southfield, Michigan, 48075, United States

RECRUITING

Enveda Investigative Site

St Louis, Missouri, 63141, United States

RECRUITING

Enveda Investigative Site

Clackamas, Oregon, 97015, United States

RECRUITING

Enveda Investigative Site

Medford, Oregon, 97504, United States

RECRUITING

Enveda Investigative Site

North Charleston, South Carolina, 29406, United States

RECRUITING

Enveda Investigative Site

McKinney, Texas, 75069, United States

RECRUITING

Enveda Investigative Site

Madison, Wisconsin, 53792, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gurpreet Ahluwalia, PhD

  Enveda Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations

CONTACT

env-294.clinicaltrials@enveda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)