Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorForesee Pharmaceuticals Co., Ltd.
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
linvemastat
DrugMatrix Metalloproteinase-12 inhibitor
Placebo
DrugPlacebo
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: linvemastat 100 mg once dailyExperimental treatment 1 intervention
Group B: linvemastat 300 mg once dailyExperimental treatment 1 intervention
Group C: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 16Secondary outcomes
1
Time to first severe asthma exacerbation
Time to first severe asthma exacerbation
Time frame
Baseline up to Week 16].2
Change in clinical laboratory testing
Change in mean blood eosinophil count.
Time frame
Baseline to Week 163
FeNO Changes
Change in mean Fraction Exhaled Nitric Oxide (FeNO).
Time frame
Baseline up to Week 164
Change in Sputum
Change in mean percentage of mucous eosinophils and neutrophils assessed by sputum analysis
Time frame
Baseline up to Week 16Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Foresee Pharmaceuticals Co., Ltd.
Lead sponsor
QPS Holdings LLC
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: