Recruiting

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

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…

ClinicalTrials.gov IDNCT07301255

PhasePHASE2

Enrollment50

SponsorEnveda Therapeutics

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma

About this study

Interventions

Drug: ENV-294 — ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Drug: Placebo — 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.

Primary outcomes

Incidence and Severity of Adverse Events (From first dose through approximately 16 weeks)

Eligibility information

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

Study locations

Enveda Investigative Site, Birmingham, Alabama 35209 United States
Enveda Investigative Site, Los Angeles, California 90025 United States
Enveda Investigative Site, San Jose, California 95117 United States
Enveda Investigative Site, West Hills, California 91307 United States
Enveda Investigative Site, Colorado Springs, Colorado 80907 United States
Enveda Investigative Site, Hialeah, Florida 33012 United States
Enveda Investigative Site, Miami, Florida 33135 United States
Enveda Investigative Site, Albany, Georgia 31707 United States
Enveda Investigative Site, Maryville, Illinois 62062 United States
Enveda Investigative Site, Kansas City, Kansas 66160 United States

Showing 10 of 20 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.