Recruiting

Phase 2

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

Sponsor:

Enveda Therapeutics

Code:

NCT07301255

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ENV-294

Placebo

Study Details

Brief summary:

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.

Conditions

Asthma

Study ID

NCT07301255

Start date

Jan 9, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ENV-294 Treatment Arm

ENV-294 will be administered to those participants randomized to the treatment arm.

placebo comparator: Placebo Arm

A placebo will be administered to those participants randomized to the placebo arm.

Interventions

ENV-294

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

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 outcome measure

Incidence and Severity of Adverse Events [ Time Frame: From first dose through approximately 16 weeks ]

Central Contacts and Locations

Central contacts

Clinical Operations

env-294.clinicaltrials@enveda.com

Locations

Enveda Investigative Site

Recruiting

Birmingham, Alabama, United States, 35209

Enveda Investigative Site

Recruiting

Los Angeles, California, United States, 90025

Enveda Investigative Site

Recruiting

San Jose, California, United States, 95117

Enveda Investigative Site

Recruiting

West Hills, California, United States, 91307

Enveda Investigative Site

Recruiting

Colorado Springs, Colorado, United States, 80907

Enveda Investigative Site

Recruiting

Hialeah, Florida, United States, 33012

Enveda Investigative Site

Recruiting

Miami, Florida, United States, 33135

Enveda Investigative Site

Recruiting

Albany, Georgia, United States, 31707

Enveda Investigative Site

Recruiting

Maryville, Illinois, United States, 62062

Enveda Investigative Site

Recruiting

Kansas City, Kansas, United States, 66160

Enveda Investigative Site

Recruiting

Owensboro, Kentucky, United States, 42301

Enveda Investigative Site

Recruiting

Southfield, Michigan, United States, 48075

Enveda Investigative Site

Recruiting

St Louis, Missouri, United States, 63141

Enveda Investigative Site

Recruiting

Clackamas, Oregon, United States, 97015

Enveda Investigative Site

Recruiting

Medford, Oregon, United States, 97504

Enveda Investigative Site

Recruiting

North Charleston, South Carolina, United States, 29406

Enveda Investigative Site

Recruiting

McKinney, Texas, United States, 75069

More Information

Sponsor

Enveda Therapeutics

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

Asthma in Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Enveda Therapeutics on 2026-07-29.