ClinicalTrials.gg
Not yet recruitingNCT07191535syMMPoniaUpdated Jul 20, 2026

Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)

A Phase 2 interventional study of linvemastat and Placebo in Asthma (Diagnosis), Pulmonary Function and Moderate-to-Severe Asthma, sponsored by Foresee Pharmaceuticals Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Foresee Pharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Asthma (Diagnosis)
  • Pulmonary Function
  • Moderate-to-Severe Asthma

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Keywords

  • central spirometry
  • type-2 (T2) high asthma
  • asthma management
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 135 is above the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Foresee Pharmaceuticals Co., Ltd. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 - 85 years at the time of signing
  • 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 value of 40% to 80% of the patient's predicted value at Screening.
  • Patients must have experienced at least once, within 2 years prior to Screening, one of the following asthma exacerbation events: Treatment with a systemic (oral or parenteral) for worsening asthma. Hospitalization or emergency medical care visit for worsening asthma.
  • Males with a partner of 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 ) must use a highly effective method of 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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 [ (NYHA) class 3 or 4].
  • Known to any component of the formulation of linvemastat or any component of the .
  • 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 (e.g., methotrexate) to treat inflammatory disease or 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 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 surface antigen (HBsAg), virus (HCV) antibody, or (HIV) infection at Screening.
  • Concurrent emphysema.
  • Use of any therapeutics that are strong inhibitors and inducers of or CYP2C8 [e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g., telithromycin), and carbamazepine].
  • History of liver dysfunction, including patients with moderate ( B) or severe (Child-Pugh C) impairment or disordered coagulation.
  • Abnormal : ventricular arrhythmias (non-sustained ventricular tachycardia [VT], multifocal or frequent premature ventricular contractions, bundle branch block or axis deviation [as assessed by PI], or abnormal Q waves). In the case of a 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:

    1. (Hg) \<10 g/dL (100 g/L)
    2. 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.
    3. count \< 70,000/μL (70,000/mm3)
    4. Serum creatinine > 1.5 x (ULN)
    5. ≤ 60 mL/min/1.73 m2 or evidence of acute kidney injury or history of severe hypersensitivity reactions to gadolinium-based contrast agents
    6. Serum total > 1.5 ULN
    7. Serum (ALT) or aspartate aminotransferase (AST) > 2 x ULN or serum alkaline phosphatase > 2 x ULN
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
135 participants (estimated)

Study arms

  • Experimental
    linvemastat 100 mg once daily

    linvemastat 100 mg once daily

    Drug: linvemastat

  • Experimental
    linvemastat 300 mg once daily

    linvemastat 300 mg once daily

    Drug: linvemastat

  • Placebo comparator
    Placebo Comparator

    Placebo once daily

    Drug: Placebo

Interventions

  • Druglinvemastat

    Matrix Metalloproteinase-12 inhibitor

    Also known as: FP-020

  • DrugPlacebo

    Placebo

06

What researchers measure

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 16

Secondary 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 16

  3. FeNO Changes

    Change in mean Fraction Exhaled Nitric Oxide (FeNO).

    Time frame: Baseline up to Week 16

  4. Change in Sputum

    Change in mean percentage of mucous eosinophils and neutrophils assessed by sputum analysis

    Time frame: Baseline up to Week 16

  5. Pre-bronchodilator FEV1 changes

    Change in mean pre-bronchodilator FEV1.

    Time frame: Baseline to Week 16

  6. Post-bronchodilator FEV1 changes

    Change in mean post-bronchodilator FEV1.

    Time frame: Baseline up to Week 16

  7. AM/PM Peak Flow changes

    Change in the mean morning and evening Peak Flow (in liters/minute).

    Time frame: Baseline up to Week 16

  8. 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

  9. Change in Asthma Control Questionnaire

    Change in ACQ score

    Time frame: Baseline up to Week 16

  10. Change in St. George's Respiratory Questionnaire

    Change in St. George's Respiratory Questionnaire (SGRQ) score.

    Time frame: Baseline to Week 16

  11. Change in clinical laboratory testing

    Change in mean neutrophil count

    Time frame: Baseline to Week 16

  12. Change in clinical laboratory testing

    Change in mean level of IgE.

    Time frame: Baseline to Week 16

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07191535
Lead sponsor
Foresee Pharmaceuticals Co., Ltd.
Collaborators
QPS Holdings LLC
Responsible party
Sponsor
First posted
Sep 25, 2025
Start date
Mar 1, 2027 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jul 20, 2026

Study contacts

Bassem Elmankabadi, MD
Contact
Bassem.elmankabadi@foreseepharma.com
+1 562-310-8718
Yisheng Lee
Contact
yisheng.lee@foreseepharma.com
408-823-4807
Bassem Elmankabadi, MD
study director · Foresee Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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