ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ENV-294, Placebo.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks. - Drug Placebo
Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Primary outcome measures
- Incidence and Severity of Adverse Events [Time frame: From first dose through approximately 16 weeks]
Secondary outcome measures (6)
- Loss of Asthma Control Events [Time frame: Baseline to Week 12]
- Time to Loss of Asthma Control [Time frame: Baseline to Week 12]
- To assess the efficacy of ENV-294 in participants with asthma [Time frame: Baseline to Week 12]
- To assess the efficacy of ENV-294 in participants with asthma [Time frame: Baseline to Week 12]
- To assess the efficacy of ENV-294 in participants with asthma [Time frame: Baseline to Week 12]
- Plasma concentration of ENV-294 [Time frame: Baseline to Week 12]
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) 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- Enveda Investigative Site — Birmingham
- Enveda Investigative Site — Los Angeles
- Enveda Investigative Site — San Jose
- Enveda Investigative Site — West Hills
- Enveda Investigative Site — Colorado Springs
- Enveda Investigative Site — Hialeah
- Enveda Investigative Site — Miami
- Enveda Investigative Site — Albany
- … and 10 more centers
Identifiers
NCT: NCT07301255 · ENV-294-211