ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
NCT ID: NCT07301255
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-12-31
2027-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ENV-294 Treatment Arm
Participants will be treated with ENV-294 if they are randomized to this treatment arm.
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.
Placebo Arm
Participants will be treated with placebo (matching the appearance of ENV-294 active drug) if they are randomized to the placebo arm.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Enveda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Gurpreet Ahluwalia, PhD
Role: STUDY_DIRECTOR
Enveda Therapeutics
Locations
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Velocity Clinical Research - Medford
Medford, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Other Identifiers
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ENV-294-211
Identifier Type: -
Identifier Source: org_study_id