ENV-294 for adults with moderate-to-severe asthma — 12-week oral treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with physician-diagnosed moderate-to-severe asthma who are stable on an inhaled corticosteroid plus a long-acting beta2-agonist are screened and randomized to receive either oral ENV-294 or placebo once daily for 12 weeks after a screening period of up to 28 days. The trial monitors safety and tolerability, measures drug levels (pharmacokinetics) and biological effects (pharmacodynamics), and evaluates effects on lung function and asthma control. Key eligibility includes pre-bronchodilator FEV1 50–80% predicted, bronchodilator reversibility, ACQ-5 between 1.25 and 3.0, and a recent history of at least one exacerbation requiring systemic steroids or emergency care. Participants attend regular on-site visits at one of three Enveda sites for testing and follow-up in a randomized, placebo-controlled design.

Why it matters

Who can join: the full rules

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

Where it's running

• Enveda Investigative Site
  Birmingham, Alabama, United States Recruiting
• Enveda Investigative Site
  Los Angeles, California, United States Recruiting
• Enveda Investigative Site
  San Jose, California, United States Recruiting
• Enveda Investigative Site
  West Hills, California, United States Recruiting
• Enveda Investigative Site
  Colorado Springs, Colorado, United States Recruiting
• Enveda Investigative Site
  Hialeah, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: env-294.clinicaltrials@enveda.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.