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Clinical Trials in the USA / NCT07301255
Recruiting Phase 2

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

NCT07301255 · tracked via the Priya Life Science USA tracker
Sponsor
Enveda Therapeutics
Phase
Phase 2
Started
2026-01-09
Last updated
2026-09-24

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

ENV-294 →Placebo

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: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence and Severity of Adverse Events — 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.

Trial sites (20)

FacilityCityRegionStatus
Enveda Investigative Site Birmingham Alabama Recruiting
Enveda Investigative Site Los Angeles California Recruiting
Enveda Investigative Site San Jose California Recruiting
Enveda Investigative Site West Hills California Recruiting
Enveda Investigative Site Colorado Springs Colorado Recruiting
Enveda Investigative Site Hialeah Florida Recruiting
Enveda Investigative Site Miami Florida Recruiting
Enveda Investigative Site Albany Georgia Recruiting
Enveda Investigative Site Maryville Illinois Recruiting
Enveda Investigative Site Kansas City Kansas Recruiting
Enveda Investigative Site Owensboro Kentucky Recruiting
Enveda Investigative Site Boston Massachusetts Recruiting
Enveda Investigative Site Southfield Michigan Recruiting
Enveda Investigative Site St Louis Missouri Recruiting
Enveda Investigative Site The Bronx New York Recruiting
Enveda Investigative Site Clackamas Oregon Recruiting
Enveda Investigative Site Medford Oregon Recruiting
Enveda Investigative Site North Charleston South Carolina Recruiting
Enveda Investigative Site McKinney Texas Recruiting
Enveda Investigative Site Madison Wisconsin Recruiting

More Enveda Therapeutics trials in the USA

A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis Recruiting
Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis Recruiting

Other trials for the same condition

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma Active, not recruiting
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma Enrolling by invitation
A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma Recruiting
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics Active, not recruiting
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07301255 on ClinicalTrials.gov ↗ ← All trials in the USA