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

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

135 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators