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

April 20, 2026 updated by: Enveda Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Enveda Investigative Site
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Enveda Investigative Site
      • San Jose, California, United States, 95117
        • Recruiting
        • Enveda Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Enveda Investigative Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Enveda Investigative Site
    • Georgia
      • Albany, Georgia, United States, 31707
        • Recruiting
        • Enveda Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Recruiting
        • Enveda Investigative Site
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Enveda Investigative Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Enveda Investigative Site
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Enveda Investigative Site
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Enveda Investigative Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Enveda Investigative Site
    • Texas
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Enveda Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • Enveda Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENV-294 Treatment Arm
ENV-294 will be administered to those participants randomized to the treatment arm.
Drug: ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Placebo Comparator: Placebo Arm
A placebo will be administered to those participants randomized to the placebo arm.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Adverse Events
Time Frame: From first dose through approximately 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of Asthma Control Events
Time Frame: Baseline to Week 12
Number and percentage of participants experiencing a loss of asthma control (LOAC) event during the treatment period, defined according to protocol-specified criteria
Baseline to Week 12
Time to Loss of Asthma Control
Time Frame: Baseline to Week 12
Time from the first dose of study drug to the first occurrence of a loss of asthma control (LOAC) event, as defined in the protocol.
Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Time Frame: Baseline to Week 12
Change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁), measured using standardized spirometry.
Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Time Frame: Baseline to Week 12
Change from Baseline in the Asthma Control Questionnaire (ACQ-5)
Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Time Frame: Baseline to Week 12
Change from Baseline in the Asthma Quality of Life Questionnaire (AQLQ)
Baseline to Week 12
Plasma concentration of ENV-294
Time Frame: Baseline to Week 12
Plasma concentrations of ENV-294 will be measured at specified time points following oral administration of the investigational drug.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enveda Therapeutics

Investigators

  • Study Director: Gurpreet Ahluwalia, PhD, Enveda Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENV-294-211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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