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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Enveda Therapeutics
Study ID
NCT07301255
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Enveda Investigative SiteBirminghamAlabama35209-
Enveda Investigative SiteLos AngelesCalifornia90025-
Enveda Investigative SiteSan JoseCalifornia95117-
Enveda Investigative SiteColorado SpringsColorado80907-
Enveda Investigative SiteHialeahFlorida33012-
Enveda Investigative SiteAlbanyGeorgia31707-
Enveda Investigative SiteOwensboroKentucky42301-
Enveda Investigative SiteSouthfieldMichigan48075-
Enveda Investigative SiteSt LouisMissouri63141-
Enveda Investigative SiteClackamasOregon97015-
Enveda Investigative SiteMedfordOregon97504-
Enveda Investigative SiteNorth CharlestonSouth Carolina29406-
Enveda Investigative SiteMcKinneyTexas75069-
Enveda Investigative SiteMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Enveda Investigative Site· Birmingham, ALEnveda Investigative Site· Los Angeles, CAEnveda Investigative Site· San Jose, CAEnveda Investigative Site· Colorado Springs, COEnveda Investigative Site· Hialeah, FLEnveda Investigative Site· Albany, GA

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