RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 28 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of ENV-294 and how it may help control asthma and improve breathing. It is for adults with moderate to severe asthma who already use an inhaled steroid and a long-acting medicine that opens the airways. Participants take ENV-294 or a placebo (a pill with no study drug) once a day for 12 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can read, understand, and sign a form agreeing to join before any study procedures.
  • Are 18 to 75 years old and have had doctor-diagnosed moderate to severe asthma for at least 12 months.
  • Have used a steady dose of an inhaled steroid plus a long-acting airway-opening medicine for at least 2 months before screening.
  • Before airway-opening medicine, can blow out 50% to 80% of the expected normal amount of air in one second at screening and the study's start.
  • Breathing tests show improvement after taking airway-opening medicine.
  • Score 1.25 to 3.0 on the ACQ-5 asthma control survey at screening and the study's start.
  • Had at least one asthma flare-up in the past 12 months that needed steroid pills or shots, a hospital stay, or emergency care.

Who can't join

  • Had a moderate or severe asthma flare-up within 4 weeks before screening, or ever had life-threatening asthma.
  • Have another serious lung disease.
  • Had bronchial thermoplasty, a heat treatment for the airways, within 2 years.
  • Have another ongoing or recurring illness that is not controlled.
  • Recently used biologic asthma medicines, which target parts of the immune system: within 6 months or 5 half-lives (a measure of how long a drug stays in the body).
  • Need medicines that weaken the immune system or frequent steroid pills or shots.
  • Smoke now, or used to smoke and have a significant smoking history.
  • Have uncontrolled high blood pressure or serious liver problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (20)

AL

CA

CO

FL

GA

IL

KS

KY

MA

MI

MO

NY

OR

SC

TX

WI