This study explores a potential new treatment for adults with moderate-to-severe asthma using a drug called linvemastat, which targets an enzyme linked to lung inflammation. Despite using standard asthma medications, many patients still struggle with symptoms, so researchers are testing whether linvemastat can improve lung function and reduce flare-ups. In a carefully controlled trial, participants receive either one of two doses of the drug or a placebo, while continuing their usual treatments. Over 16 weeks, scientists monitor breathing capacity, symptom control, and safety to determine if linvemastat could offer a meaningful new option for asthma management.
This clinical study investigates the potential of a new drug, linvemastat, to improve outcomes for adults with moderate-to-severe asthma who continue to experience symptoms despite using standard treatments like inhaled corticosteroids and long-acting beta-agonists. Linvemastat works by blocking an enzyme called MMP-12, which is believed to contribute to lung inflammation and tissue damage in asthma. The trial is a Phase 2, randomized, double-blind, placebo-controlled study involving approximately 135 participants across multiple global sites. Participants are assigned to receive either 100 mg or 300 mg of linvemastat, or a placebo, once daily for 16 weeks, while continuing their regular asthma medications. Researchers are primarily measuring changes in lung function, specifically the amount of air a person can forcefully exhale in one second (FEV₁), as well as tracking asthma flare-ups, use of rescue inhalers, and markers of inflammation. Safety is closely monitored through lab tests, heart monitoring, and physical exams. The goal is to determine whether linvemastat can offer a meaningful new option for patients whose asthma remains difficult to control, potentially improving both respiratory health and overall quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
Matrix Metalloproteinase-12 inhibitor
Placebo
The mean change in trough FEV1 assessed by central spirometry
FEV1 (measured in liters by spirometer), and the trough measurement is taken 24 hours after the morning dose on the previous day of the randomized study drug. The Baseline is defined as the last available FEV1 measurement taken prior to the first dose of the randomized study drug.
Time frame: Baseline to Week 16
Time to first severe asthma exacerbation
Time to first severe asthma exacerbation
Time frame: Baseline up to Week 16].
Change in clinical laboratory testing
Change in mean blood eosinophil count.
Time frame: Baseline to Week 16
FeNO Changes
Change in mean Fraction Exhaled Nitric Oxide (FeNO).
Time frame: Baseline up to Week 16
Change in Sputum
Change in mean percentage of mucous eosinophils and neutrophils assessed by sputum analysis
Time frame: Baseline up to Week 16
Pre-bronchodilator FEV1 changes
Change in mean pre-bronchodilator FEV1.
Time frame: Baseline to Week 16
Post-bronchodilator FEV1 changes
Change in mean post-bronchodilator FEV1.
Time frame: Baseline up to Week 16
AM/PM Peak Flow changes
Change in the mean morning and evening Peak Flow (in liters/minute).
Time frame: Baseline up to Week 16
Use of Inhaled Corticosteroids (ICS) or Long-Acting Beta-Agonists (LABA)
Change in the mean number of inhalations/days of ICS or LABA.
Time frame: Baseline to Week 16
Change in Asthma Control Questionnaire
Change in ACQ score
Time frame: Baseline up to Week 16
Change in St. George's Respiratory Questionnaire
Change in St. George's Respiratory Questionnaire (SGRQ) score.
Time frame: Baseline to Week 16
Change in clinical laboratory testing
Change in mean neutrophil count
Time frame: Baseline to Week 16
Change in clinical laboratory testing
Change in mean level of IgE.
Time frame: Baseline to Week 16
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