Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults (NCT07301255) is a Phase 2 interventional studying Asthma, sponsored by Enveda Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to read, understand, and sign an willing to sign a consent form 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, defined as ≥12% and ≥200 mL improvement in FEV₁ (or ≥20% increase in peak expiratory flow) after short-acting bronchodilator use. - ACQ-5 score ≥1.25 and ≤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. Who Should NOT Join This Trial: - Had a moderate or severe asthma exacerbation within 4 weeks before screening. - Have a history of life-threatening asthma, including intubation or respiratory arrest. - Have any other significant pulmonary disease (e.g., COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, tuberculosis, lung cancer, or eosinophilic syndromes). - Had bronchial thermoplasty within 2 years before screening. - Used biologic therapies for asthma (e.g., benralizumab, mepolizumab, reslizumab, omalizumab, dupilumab, or tezepelumab) within 6 months or 5 half-lives prior to baseline. - Require immunosuppressive medications or frequent systemic corticosteroids (more than 3 courses in the past 6 months). - Are current smokers or former smokers with \>10 pack-year history or who quit within 6 months before screening. - Have uncontrolled hypertension (systolic ≥160 mmHg or diastolic \>95 mmHg). - Have significant hepatic impairment or any other condition that, in the investigator's opinion, would interfere with study participation or interpretation of results. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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, defined as ≥12% and ≥200 mL improvement in FEV₁ (or ≥20% increase in peak expiratory flow) after short-acting bronchodilator use. * ACQ-5 score ≥1.25 and ≤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: * Had a moderate or severe asthma exacerbation within 4 weeks before screening. * Have a history of life-threatening asthma, including intubation or respiratory arrest. * Have any other significant pulmonary disease (e.g., COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, tuberculosis, lung cancer, or eosinophilic syndromes). * Had bronchial thermoplasty within 2 years before screening. * Used biologic therapies for asthma (e.g., benralizumab, mepolizumab, reslizumab, omalizumab, dupilumab, or tezepelumab) within 6 months or 5 half-lives prior to baseline. * Require immunosuppressive medications or frequent systemic corticosteroids (more than 3 courses in the past 6 months). * Are current smokers or former smokers with \>10 pack-year history or who quit within 6 months before screening. * Have uncontrolled hypertension (systolic ≥160 mmHg or diastolic \>95 mmHg). * Have significant hepatic impairment or any other condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.

Treatments Being Tested

DRUG

ENV-294

ENV-294 is an orally administered investigational capsule formulation. Participants receive 800 milligrams (mg) once daily by mouth for 12 weeks. Capsules are taken with water, at approximately the same time each day, with or without food.

DRUG

Placebo

Matching oral capsule that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Locations (14)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

AllerVie Clinical Research

Birmingham, Alabama, United States

California Allergy and Asthma Medical

Los Angeles, California, United States

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Asthma and Allergy Associates

Colorado Springs, Colorado, United States

New Life Medical Research Center

Hialeah, Florida, United States

Georgia Pollens Clinical Research Centers

Albany, Georgia, United States

Allergy & Asthma Specialists

Owensboro, Kentucky, United States

Revive Research Institute

Southfield, Michigan, United States

The Clinical Research Center

St Louis, Missouri, United States

Portland Allergy & Asthma

Clackamas, Oregon, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Monroe Biomedical Research

North Charleston, South Carolina, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07301255), the sponsor (Enveda Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07301255 clinical trial studying?

Who can participate in NCT07301255?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07301255?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07301255. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07301255. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.