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NCT07301255RecruitingPhase 2

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Asthma

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
10 Dec 2025
Start date
9 Jan 2026
Primary completion date
31 Dec 2026
Lead sponsor
Enveda Therapeutics
Diseases
Asthma
NCT number
NCT07301255

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 50
  • From 9 Jan 2026 to the primary completion date, 31 Dec 2026
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
  • 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

Other illness

  • History of life-threatening asthma
  • Other significant pulmonary disease
  • Uncontrolled hypertension
  • Significant hepatic impairment

Other

  • Recent bronchial thermoplasty (within 2 years)
  • Current smokers or former smokers with significant smoking history

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Enveda Investigative Site
Coordinator of this site? Confirm its status
AlbanyUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
ClackamasUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
HialeahUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
MaryvilleUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
McKinneyUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
MedfordUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
North CharlestonUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
OwensboroUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
San JoseUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
SouthfieldUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting
Enveda Investigative Site
Coordinator of this site? Confirm its status
West HillsUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.