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
Qualifiers
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
Treatments tested in this trial
- ENV-294
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov