A Phase 2 Study Evaluating the Safety, Effects, and Blood Levels of Oral ENV-294 in Adults with Moderate to Severe Asthma Taking Inhaled Steroids and Long-Acting Beta2-Agonists

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential effectiveness of the investigational drug ENV-294 in adults with moderate to severe asthma who are already using inhaled corticosteroids and long-acting beta2-agonists. This phase 2, randomized, double-blind, placebo-controlled study aims to better understand how ENV-294 works and how safe it is for this population. The study is sponsored by Enveda Therapeutics and involves adult participants aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least one year. Participants will be randomly assigned to receive either oral ENV-294 tablets or matching placebo tablets once daily for 12 weeks. Prior to starting treatment, there is a screening period of up to 28 days to confirm eligibility based on lung function, asthma control, and medical history. Those in the treatment arm will take ENV-294 under supervision, while those in the placebo arm will take a similar-looking tablet without active drug. All participants continue their background asthma treatment with inhaled corticosteroids and long-acting beta2-agonists. Throughout the study, participants will attend scheduled visits for monitoring safety, measuring drug levels in the blood, and evaluating asthma control and lung function. Assessments include tracking adverse events, lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. The primary outcome is the incidence and severity of adverse events from the first dose through approximately 16 weeks. Participants are observed closely to understand how ENV-294 affects asthma symptoms and overall health during and shortly after the 12-week treatment period.

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults