About this trial
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.
Eligibility criteria
Qualifiers
Patients aged 18 - 85 years at the time of signing informed consent
Patient is able to provide written informed consent.
Documented physician´s diagnosis of Type 2 high asthma, as per the Global Initiative for Asthma (GINA) 2023 guideline 2023 at Screening.
Patients with existing treatment with at least low to medium doses of ICS therapy in combination with LABA as a second controller for at least 90 days and a stable/optimized dose ≥30 days prior to Day 1. Patients on triple therapy with a long-acting muscarinic antagonist (LAMA) will be excluded.
Disqualifiers
Pregnant or breastfeeding.
Current smoker (including vaping) or cessation of smoking within the 6 months prior to Day 1, or > 10 pack-year history of smoking.
Participation in another clinical trial of an investigational agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer, prior to randomization.
Evidence of COVID-19 infection at Screening, as judged by the Investigator.
Trial design
Treatments tested in this trial
- linvemastat
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Foresee Pharmaceuticals Co., Ltd.
Lead sponsor
QPS Holdings LLC
Collaborator