ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEnveda Therapeutics
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
ENV-294
DrugENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Placebo
DrugMatching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ENV-294 Treatment ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and Severity of Adverse Events
Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
Time frame
From first dose through approximately 16 weeksSecondary outcomes
1
Loss of Asthma Control Events
Number and percentage of participants experiencing a loss of asthma control (LOAC) event during the treatment period, defined according to protocol-specified criteria
Time frame
Baseline to Week 122
Time to Loss of Asthma Control
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.
Time frame
Baseline to Week 123
To assess the efficacy of ENV-294 in participants with asthma
Change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁), measured using standardized spirometry.
Time frame
Baseline to Week 124
To assess the efficacy of ENV-294 in participants with asthma
Change from Baseline in the Asthma Control Questionnaire (ACQ-5)
Time frame
Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov