ENV-294 taken daily by adults with moderate-to-severe asthma
Tests ENV-294 against placebo in adults with moderate-to-severe asthma.
Plain-language title generated from the registry record
Registry title: ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
Key facts
- Where
- Albany, Birmingham, Boston, Clackamas, Colorado Springs, Hialeah, Kansas City, Los Angeles, Madison, Maryville, McKinney, Medford, Miami, North Charleston, Owensboro, San Jose, Southfield, St Louis, The Bronx, and West Hills, United StatesSee the 20 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07301255, who can take part
Where in United States
- AlbanyAlbany, United StatesTaking people
- BirminghamBirmingham, United StatesTaking people
- BostonBoston, United StatesTaking people
- ClackamasClackamas, United StatesTaking people
- Colorado SpringsColorado Springs, United StatesTaking people
- HialeahHialeah, United StatesTaking people
- Kansas CityKansas City, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- MadisonMadison, United StatesTaking people
- MaryvilleMaryville, United StatesTaking people
- McKinneyMcKinney, United StatesTaking people
- MedfordMedford, United StatesTaking people
- MiamiMiami, United StatesTaking people
- North CharlestonNorth Charleston, United StatesTaking people
- OwensboroOwensboro, United StatesTaking people
- San JoseSan Jose, United StatesTaking people
- SouthfieldSouthfield, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
- The BronxThe Bronx, United StatesTaking people
- West HillsWest Hills, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Enveda Therapeutics
- Trial code
- NCT07301255
- Record updated
- 24 September 2026
- Original description
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).Read full original descriptionShow less
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
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.
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); 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; History of life-threatening asthma; Other significant pulmonary disease; Uncontrolled hypertension; Significant hepatic impairment; Recent bronchial thermoplasty (within 2 years); Current smokers or former smokers with significant smoking history.