Potential Treatment for Moderate to Severe Asthma

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Enveda Therapeutics
Must be taking: Inhaled corticosteroids, Long-acting beta₂-agonists
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a new study drug, ENV-294, to determine its effectiveness for individuals with moderate to severe asthma, who are not getting sufficient relief from their current treatment. Researchers aim to assess the drug's impact on asthma control and lung function, and identify any potential side effects.

Will I have to stop taking my current medications?

Some medications can be continued and others will need to be stopped. It's best to discuss this with the study doctor to understand how your medications might interact with the trial.

Is there any evidence suggesting that ENV-294 is likely to be safe for humans?

Research has shown that ENV-294 has been well-tolerated in earlier studies. One study found that ENV-294 had a good safety record, with participants not experiencing serious health issues. Even at higher doses, no harmful effects or serious side effects were reported. These findings suggest that ENV-294 is likely safe for humans, based on past studies.

Why do researchers think this study treatment might be promising?

Unlike the standard asthma treatments like inhaled corticosteroids or bronchodilators, ENV-294 is unique because it targets a different pathway involved in asthma attacks. This new drug acts on specific receptors in the immune system, potentially reducing inflammation more effectively and with fewer side effects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive oral ENV-294 or placebo once daily for 12 weeks

12 weeks
Regular visits for safety monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)