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ENV-294 for Moderate-to-Severe Asthma

This study is testing a new oral medication called ENV-294 for adults aged 18-75 with moderate-to-severe asthma. You would take ENV-294 or a placebo (a pill with no active medicine) once daily for 12 weeks. The main goal is to see how safe ENV-294 is and if you experience any side effects. Researchers will also look at how your body handles the drug and if it helps with your asthma. To join, you need to have been diagnosed with moderate-to-severe asthma for at least 12 months and be on stable treatment with an inhaled corticosteroid (ICS) and a long-acting beta₂-agonist (LABA). The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an interventional study involving 50 participants. It compares ENV-294 to a placebo, meaning some participants will receive the active drug and others will receive an inactive pill.
What's involved
You would take an oral tablet once daily for 12 weeks. There will be a screening period of up to 28 days, and study visits will monitor your safety, drug levels, and asthma control.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first dose through approximately 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07301255

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Enveda Therapeutics
~50 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:ENV-294Placebo

At a glance

Recruiting sites
17 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and Severity of Adverse Events
Measured over From first dose through approximately 16 weeks

Conditions

Asthma

Explore related trials

Asthma

Where it's being run

18 sites across 14 states
California3
Florida2
Oregon2
Alabama1
Colorado1
Georgia1
Illinois1
Kansas1

Study leadership

  • Gurpreet Ahluwalia, PhD · STUDY_DIRECTOR · Enveda Therapeutics, Inc.

Who to contact

Clinical Operations
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence and Severity of Adverse EventsFrom 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.