Asthma (Diagnosis)Phase 2syMMPoniaNCT07191535
Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)
A Phase 2 study testing linvemastat in people with Asthma (Diagnosis) and Pulmonary Function, run by Foresee Pharmaceuticals Co., Ltd..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma (Diagnosis), Pulmonary Function, Moderate-to-Severe Asthma
- What is being tested?
- linvemastat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- An ACQ score ≥ 1.5 at Screening.
- Patients with a pre-bronchodilator FEV1 value of 40% to 80% of the patient's predicted value at Screening.
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- Patients must have experienced at least once, within 2 years prior to Screening, one of the following asthma exacerbation events: Treatment with a systemic steroid (oral or parenteral) for worsening asthma. Hospitalization or emergency medical care visit for worsening asthma.
- Males with a partner of childbearing potential must use a condom for the duration of study treatment and at least 96 hours after discontinuing the study drug.
- Female patients of childbearing potential (including those < 1 year post-menopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation during the conduct of the study and for 30 days after the last dose of study drug. Highly effective contraceptive measures for female patients of childbearing potential include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable. intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (when partner is the sole sexual partner of the female patient and when the partner has received medical assessment of the surgical success), sexual abstinence.
- Women not of childbearing potential are defined as: Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women <45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening OR Have a congenital or acquired condition that prevents childbearing.
Who cannot join
- 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.
- Advanced congestive heart failure [New York Heart Association (NYHA) class 3 or 4].
- Known hypersensitivity to any component of the formulation of linvemastat or any component of the excipient.
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- Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation.
- History of solid organ transplant.
- Anti-immunoglobulin E (IgE) therapy [e.g., omalizumab (Xolair®)] within 130 days prior to Screening or any other biologic therapy [including anti-TSLP, anti-IL-4/4R or IL-5/5R monoclonal antibodies (mAb)] or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 2 months or 5 half-lives prior to Screening, whichever is longer.
- Evidence of active tuberculosis (TB) infection at Screening, as judged by the Investigator.
- Active acute or chronic psychiatric illness that, in the opinion of the Investigator, may prevent from complying with study instructions.
- Known positive history of malignancy within 5 years of Screening (with the exception of basal cell skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy).
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) infection at Screening.
- Concurrent emphysema.
- Use of any therapeutics that are strong inhibitors and inducers of CYP3A4 or CYP2C8 [e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g., telithromycin), and carbamazepine].
- History of liver dysfunction, including patients with moderate (Child-Pugh B) or severe (Child-Pugh C) impairment or disordered coagulation.
- Abnormal ECG: ventricular arrhythmias (non-sustained ventricular tachycardia [VT], multifocal or frequent premature ventricular contractions, clinically significant bundle branch block or axis deviation [as assessed by PI], or abnormal Q waves). In the case of a corrected QT interval using Fridericia's formula (QTcF) interval >450 ms (men) or >480 ms (women; patients with bundle branch block) or PR (P to QRS) interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline.
- Known uncontrolled hypertension or diabetes at the discretion of the Investigator.
- Any condition that required hospitalization (except for asthma exacerbation) within the 3 months prior to Day 1 or is likely to require so during the study.
- Clinically significant abnormalities in the Screening physical examination, medical history, vital signs, ECG, or clinical laboratory tests that are not known to be due to concurrent asthma in the opinion of the Investigator and Medical Monitor should preclude the patient's participation in the clinical study.
- The following laboratory parameters are excluded:
- Hemoglobin (Hg) <10 g/dL (100 g/L)
- White blood cells (WBC) < 3000/μL (< 3000/mm3). African American patients who are known to have low WBC of < 3000/μL but ≥ 1500/μL will be eligible.
- Platelet count < 70,000/μL (70,000/mm3)
- Serum creatinine > 1.5 x upper limit of normal (ULN)
- Glomerular filtration rate ≤ 60 mL/min/1.73 m2 or evidence of acute kidney injury or history of severe hypersensitivity reactions to gadolinium-based contrast agents
- Serum total bilirubin > 1.5 ULN
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN or serum alkaline phosphatase > 2 x ULN
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multinational Randomized Double-Blind Placebo-Controlled Phase 2 Study to Evaluate the Effect of Linvemastat (FP-020) in Patients With Partially Controlled Asthma on Inhaled Corticosteroids and Long-Acting Beta-Agonists (syMMPonia Study)
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.
Read the detailed description
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.
- Being tested
- linvemastat, Placebo
- Keywords
- central spirometry, type-2 (T2) high asthma, asthma management
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linvemastatDrug
Also called FP-020
Matrix Metalloproteinase-12 inhibitor
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| linvemastat 100 mg once daily | Experimental | linvemastat 100 mg once daily Receives: Drug: linvemastat |
| linvemastat 300 mg once daily | Experimental | linvemastat 300 mg once daily Receives: Drug: linvemastat |
| Placebo Comparator | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Secondary outcomes (12)
Time to first severe asthma exacerbation
Time to first severe asthma exacerbation
Measured: Baseline up to Week 16].
Change in clinical laboratory testing
Change in mean blood eosinophil count.
Measured: Baseline to Week 16
FeNO Changes
Change in mean Fraction Exhaled Nitric Oxide (FeNO).
Measured: Baseline up to Week 16
Change in Sputum
Change in mean percentage of mucous eosinophils and neutrophils assessed by sputum analysis
Measured: Baseline up to Week 16
Pre-bronchodilator FEV1 changes
Change in mean pre-bronchodilator FEV1.
Measured: Baseline to Week 16
Post-bronchodilator FEV1 changes
Change in mean post-bronchodilator FEV1.
Measured: Baseline up to Week 16
AM/PM Peak Flow changes
Change in the mean morning and evening Peak Flow (in liters/minute).
Measured: 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.
Measured: Baseline to Week 16
Change in Asthma Control Questionnaire
Change in ACQ score
Measured: Baseline up to Week 16
Change in St. George's Respiratory Questionnaire
Change in St. George's Respiratory Questionnaire (SGRQ) score.
Measured: Baseline to Week 16
Change in clinical laboratory testing
Change in mean neutrophil count
Measured: Baseline to Week 16
Change in clinical laboratory testing
Change in mean level of IgE.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC
- Responsible party
- Sponsor
- Investigators
- Bassem Elmankabadi, MD, Study director, Foresee Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191535
- Sponsor's protocol ID
- FP-020C-25-001
- Acronym
- syMMPonia
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Randomized Double-Blind Placebo-Controlled Phase 2 Study to Evaluate the Effect of Linvemastat (FP-020) in Patients With Partially Controlled Asthma on Inhaled Corticosteroids and Long-Acting Beta-Agonists (syMMPonia Study)
- ClinicalTrials.gov ID
- NCT07191535
- Acronym / sponsor ID
- syMMPonia / FP-020C-25-001
- Keywords
- central spirometry, type-2 (T2) high asthma, asthma management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| linvemastat 100 mg once daily | Experimental | Drug: linvemastatlinvemastat 100 mg once daily |
| linvemastat 300 mg once daily | Experimental | Drug: linvemastatlinvemastat 300 mg once daily |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- An ACQ score ≥ 1.5 at Screening.
Key exclusion criteria (28 listed)
- 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.
- Advanced congestive heart failure [New York Heart Association (NYHA) class 3 or 4].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linvemastatAlso: FP-020Matrix Metalloproteinase-12 inhibitor | Drug | linvemastat 100 mg once daily, linvemastat 300 mg once daily |
| PlaceboPlacebo | Drug | Placebo Comparator |
Primary outcome
The mean change in trough FEV1 assessed by central spirometry
Time frame: Baseline to Week 16
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.
12 secondary outcomes
Time to first severe asthma exacerbation
Time frame: Baseline up to Week 16].
Change in clinical laboratory testing
Time frame: Baseline to Week 16
FeNO Changes
Time frame: Baseline up to Week 16
Change in Sputum
Time frame: Baseline up to Week 16
Pre-bronchodilator FEV1 changes
Time frame: Baseline to Week 16
Post-bronchodilator FEV1 changes
Time frame: Baseline up to Week 16
AM/PM Peak Flow changes
Time frame: Baseline up to Week 16
Use of Inhaled Corticosteroids (ICS) or Long-Acting Beta-Agonists (LABA)
Time frame: Baseline to Week 16
Change in Asthma Control Questionnaire
Time frame: Baseline up to Week 16
Change in St. George's Respiratory Questionnaire
Time frame: Baseline to Week 16
Change in clinical laboratory testing
Time frame: Baseline to Week 16
Change in clinical laboratory testing
Time frame: Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bassem Elmankabadi, MD study director
Foresee Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing linvemastat in people with Asthma (Diagnosis) and Pulmonary Function, run by Foresee Pharmaceuticals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bassem Elmankabadi, MD (+1 562-310-8718, Bassem.elmankabadi@foreseepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in trough FEV1 assessed by central spirometry (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.