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NCT Number: NCT07301255

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 safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Enveda Investigative Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: From first dose through approximately 16 weeks

    Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.

Secondary outcomes

  1. Loss of Asthma Control Events

    Time frame: Baseline to Week 12

    Number and percentage of participants experiencing a loss of asthma control (LOAC) event during the treatment period, defined according to protocol-specified criteria

  2. Time to Loss of Asthma Control

    Time frame: Baseline to Week 12

    Time from the first dose of study drug to the first occurrence of a loss of asthma control (LOAC) event, as defined in the protocol.

  3. To assess the efficacy of ENV-294 in participants with asthma

    Time frame: Baseline to Week 12

    Change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁), measured using standardized spirometry.

  4. To assess the efficacy of ENV-294 in participants with asthma

    Time frame: Baseline to Week 12

    Change from Baseline in the Asthma Control Questionnaire (ACQ-5)

  5. To assess the efficacy of ENV-294 in participants with asthma

    Time frame: Baseline to Week 12

    Change from Baseline in the Asthma Quality of Life Questionnaire (AQLQ)

  6. Plasma concentration of ENV-294

    Time frame: Baseline to Week 12

    Plasma concentrations of ENV-294 will be measured at specified time points following oral administration of the investigational drug.

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Recruiting

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Sponsors and collaborators

Lead sponsor

Enveda Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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