Asthma
Conditions
Keywords
Asthma in Adults
Brief summary
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
DRUGENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
DRUGPlacebo
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.
Sponsors
Enveda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loss of Asthma Control Events | Baseline to Week 12 | Number and percentage of participants experiencing a loss of asthma control (LOAC) event during the treatment period, defined according to protocol-specified criteria |
| Time to Loss of Asthma Control | Baseline to Week 12 | Time from the first dose of study drug to the first occurrence of a loss of asthma control (LOAC) event, as defined in the protocol. |
| To assess the efficacy of ENV-294 in participants with asthma | Baseline to Week 12 | Change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁), measured using standardized spirometry. |
| Plasma concentration of ENV-294 | Baseline to Week 12 | Plasma concentrations of ENV-294 will be measured at specified time points following oral administration of the investigational drug. |
Countries
United States
Contacts
CONTACTClinical Operations
STUDY_DIRECTORGurpreet Ahluwalia, PhD
Enveda Therapeutics, Inc.
Outcome results
None listed