ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
Recruiting
Phase 2Interventional Study
Asthma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Enveda Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe asthma. Participants will take either the study drug ENV-294 or a placebo once a day for 12 weeks while continuing their asthma treatments.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroidsLong-acting beta₂-agonists
You may be able to join if
I can read and sign an informed consent form.
I am between 18 and 75 years old.
I have had moderate to severe asthma for at least 12 months.
I have been on inhaled corticosteroids and a long-acting beta₂-agonist for at least 2 months.
My lung function is between 50% and 80% of normal.
I have had at least one asthma exacerbation in the past year.
You may not be able to join if
I have had a moderate or severe asthma exacerbation in the last 4 weeks.
I have a history of life-threatening asthma.
I have other significant lung diseases.
I have had bronchial thermoplasty in the last 2 years.
I currently have uncontrolled other illnesses.
I have used biologic therapies for asthma in the last 6 months.
I smoke or have a significant smoking history.
I have uncontrolled high blood pressure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 u…
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.
Trial Locations
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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) …
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
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