[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Foresee Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100607667","phase-2-effect-of-linvemastat-in-patients-with-partially-controlled-asthma-symmponia-100607667",false,"NCT07191535","Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)","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)","syMMPonia","Inclusion Criteria:\n\n* Patients aged 18 - 85 years at the time of signing informed consent\n* Patient is able to provide written informed consent.\n* Documented physician´s diagnosis of Type 2 high asthma, as per the Global Initiative for Asthma (GINA) 2023 guideline 2023 at Screening.\n* 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\u002Foptimized dose ≥30 days prior to Day 1. Patients on triple therapy with a long-acting muscarinic antagonist (LAMA) will be excluded.\n* An ACQ score ≥ 1.5 at Screening.\n* Patients with a pre-bronchodilator FEV1 value of 40% to 80% of the patient's predicted value at Screening.\n* 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.\n* 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.\n* Female patients of childbearing potential (including those \\\u003C 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.\n* 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 \\\u003C45 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\u002For bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Focclusion at least 6 weeks prior to Screening OR Have a congenital or acquired condition that prevents childbearing.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Current smoker (including vaping) or cessation of smoking within the 6 months prior to Day 1, or \\> 10 pack-year history of smoking.\n* Participation in another clinical trial of an investigational agent within 3 months (small molecule) \u002F 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer, prior to randomization.\n* Evidence of COVID-19 infection at Screening, as judged by the Investigator.\n* Advanced congestive heart failure \\[New York Heart Association (NYHA) class 3 or 4\\].\n* Known hypersensitivity to any component of the formulation of linvemastat or any component of the excipient.\n* 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.\n* History of solid organ transplant.\n* 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\u002F4R or IL-5\u002F5R 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.\n* Evidence of active tuberculosis (TB) infection at Screening, as judged by the Investigator.\n* Active acute or chronic psychiatric illness that, in the opinion of the Investigator, may prevent from complying with study instructions.\n* 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).\n* Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) infection at Screening.\n* Concurrent emphysema.\n* 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\\].\n* History of liver dysfunction, including patients with moderate (Child-Pugh B) or severe (Child-Pugh C) impairment or disordered coagulation.\n* 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.\n* Known uncontrolled hypertension or diabetes at the discretion of the Investigator.\n* 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.\n* 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.\n* The following laboratory parameters are excluded:\n\n  1. Hemoglobin (Hg) \\\u003C10 g\u002FdL (100 g\u002FL)\n  2. White blood cells (WBC) \\\u003C 3000\u002FμL (\\\u003C 3000\u002Fmm3). African American patients who are known to have low WBC of \\\u003C 3000\u002FμL but ≥ 1500\u002FμL will be eligible.\n  3. Platelet count \\\u003C 70,000\u002FμL (70,000\u002Fmm3)\n  4. Serum creatinine \\> 1.5 x upper limit of normal (ULN)\n  5. Glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m2 or evidence of acute kidney injury or history of severe hypersensitivity reactions to gadolinium-based contrast agents\n  6. Serum total bilirubin \\> 1.5 ULN\n  7. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 x ULN or serum alkaline phosphatase \\> 2 x ULN","ALL","18 Years","85 Years",{"count":21,"type":22},135,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29,30],"Asthma (Diagnosis)","Pulmonary Function","Moderate-to-Severe Asthma",[32,33,34],"central spirometry","type-2 (T2) high asthma","asthma management","NOT_YET_RECRUITING","2025-10-15",{"date":38,"type":39},"2025-10-20","ACTUAL",{"date":41,"type":22},"2026-01-01",{"date":43,"type":22},"2027-09-01",{"name":45,"class":46},"Foresee Pharmaceuticals Co., Ltd.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100552645","phase-2-study-to-evaluate-safety-and-efficacy-of-mirivadelgat-in-ph-ild-100552645","NCT06475781","Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD","A Multinational Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Mirivadelgat, an Aldehyde Dehydrogenase 2 Activator, in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","WINDWARD","Inclusion Criteria:\n\n1. A clinical diagnosis of PH-ILD.\n2. Subject voluntarily gives informed consent.\n3. Subjects aged between 18 and 85 years at the time of signing informed consent.\n4. Subjects must agree to practice protocol-defined birth control during the study period.\n\n   * Males with a partner of childbearing potential must practice protocol-defined birth control for the duration of treatment and at least 96 hours after discontinuing the IP.\n   * Female subjects of childbearing of potential (including those \\\u003C1-year post menopausal) must practice protocol-defined birth control during the conduct of the study and for 30 days after the last dose of IP (males only during exposure to IP).\n   * Women not of childbearing potential are defined as:\n\n     1. Post-menopausal women (at least 12 months with no menses without an alternative medical cause); in women \\\u003C45 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\n     2. Have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to screening; OR\n     3. Have a congenital or acquired condition that prevents childbearing.\n5. The subject has a confirmed diagnosis of any form of interstitial lung disease based on high resolution computed tomography (HRCT) of the chest within 180 days prior to screening or at screening or a historical surgical biopsy (or other appropriate tissue sampling (e.g., cryobiopsy). The subject can have other findings (e.g., emphysema) if this is not the predominant feature on the scan.\n6. Subjects have undergone RHC during the screening period with the following documented parameters:\n\n   * Pulmonary vascular resistance (PVR) ≥4 Wood units and\n   * Pulmonary capillary wedge pressure (PCWP) of ≤12 mmHg \\[if PVR ≥4 Wood units to \\\u003C6.25 Wood units\\] or PCWP ≤15 mmHg \\[if PVR ≥6.25 Wood units\\] (a left ventricular end diastolic pressure \\[LVEDP\\] will be acceptable if a reliable PCWP cannot be obtained) and\n   * A mean pulmonary arterial pressure (PAP) of \\>20 mmHg.\n7. Subjects must have a baseline 6-minute walk distance ≥100 meters and ≤500 meters.\n8. Subjects agree to a repeat RHC, Chest CT, and MRI prior to study completion.\n9. Subjects on chronic treatment for underlying lung disease (i.e., nintedanib or pirfenidone or immunosuppressive agents etc.) must be on a stable\u002Foptimized dose for ≥30 days prior to screening and have been receiving treatment for ≥90 days.\n10. Subjects on supportive medications (e.g., inhalers for asthma) must be on stable doses for ≥30 days prior to screening.\n11. In the Investigator's opinion, the subject must be able to consent for themselves and communicate with local staff using interpreters if necessary. Subjects must agree to attend all study visits and be contactable through a cellular device or landline.\n12. Subjects must have clinical laboratory values within normal ranges or \\\u003C1.5 times the upper limit of normal (ULN) as specified by the testing laboratory.\n13. Pulmonary function test (PFT) showing a percent predicted forced vital capacity (FVC) \\\u003C70% of predicted and diffusion capacity of carbon monoxide (DLCO) \\\u003C70% corrected for hemoglobin (Hb) value ≥25% and ≤90% at screening (DLCO determined locally must be \\\u003C70%) using the American Thoracic Society (ATS) standards.\n14. Subjects with a prior diagnosis of connective tissue diseases, specifically systemic sclerosis (scleroderma), systemic lupus erythematosus, Sjogren's disease, polymyositis\u002Fdermatomyositis\u002Fantisynthetase syndrome, rheumatoid arthritis can be included in the study, but no more than 20% of total subjects.\n15. Negative serology test for hepatitis B surface antigen and hepatitis C antibody at Screening Visit.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Subject has another concomitant diagnosis of pulmonary hypertension not otherwise considered to be PH-ILD. This would include and is not limited to the concomitant presence of thromboembolic disease, untreated\u002Finadequately treated obstructive sleep apnea, human immunodeficiency virus (HIV), methamphetamine or anorexigenic drug use, and other conditions of the WHO Group 1, 2, 4, and 5 classifications.\n2. Subject has evidence of clinically significant left-sided heart disease within 6 months as defined by:\n\n   * Left ventricular ejection fraction \\\u003C40% as assessed by echocardiography.\n   * More than mild left-sided valvulopathy (e.g., worse than mild mitral stenosis or regurgitation and worse than mild aortic stenosis or regurgitation).\n   * LVEDP or PCWP \\>15 mmHg (or \\>12 mmHg if PVR ≥4 to 6.25 Wood units).\n3. Subjects must NOT have 3 or more of the following left ventricular disease\u002Fdysfunction risk factors at screening:\n\n   * Body mass index (BMI) ≥30 kg\u002Fm2.\n   * Uncontrolled diabetes, HbA1C \\>9.5%, urine glycosuria \\>1.0 g\u002Fdl, or presence of diabetic ketoacidosis\n   * History of significant coronary disease within 6 months of screening as demonstrated by any of the following:\n\n     1. History of myocardial infarction or acute coronary syndrome (unstable angina), or\n     2. Percutaneous coronary intervention or percutaneous transluminal angioplasty, or previous coronary artery bypass graft, or\n     3. Evidence of coronary artery disease (\\>50% stenosis in at least one major coronary artery) or abnormal nuclear stress test.\n4. The subject is receiving \\>10 L\u002Fmin of oxygen supplementation by any mode of delivery at rest.\n5. The subject has received any PH-approved therapy, including phosphodiesterase type 5 inhibitor, soluble guanylate cyclase inhibitor, endothelin receptor antagonist, or parenteral or oral prostacyclin therapy (excluding vasoreactivity testing) within 60 days of randomization or 5 half-lives. Inhaled prostacyclin (e.g., inhaled treprostinil) on stable doses for ≥30 days prior to screening will be allowed irrespective of local approval (as per ESC\u002FERS 2022).\n6. Use of any potent inhibitors and potent inducers of cytochrome P450 3A4 (CYP3A4) (e.g., boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and\u002For dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, telithromycin, troleandomycin, voriconazole, clarithromycin, idelalisib, nefazodone, nelfinavir, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort).\n7. Recent exacerbation of underlying lung disease or active pulmonary\u002Fupper respiratory tract infection within 4 weeks of randomization.\n8. Any current active malignancy (this does not include localized cancers such as basal or squamous cell carcinoma of the skin). Any history of malignancy that is likely to result in mortality or require significant medical or surgical intervention within the following year.\n9. Chronic kidney disease Stage IV or greater (i.e., eGFR ˂30 mL\u002Fmin\u002F1.73m2) or evidence of acute kidney injury.\n10. The subject has a history of congenital heart disease irrespective of any prior treatment of surgical intervention\n11. Use of tobacco, e-cigarette, nicotine, or marijuana products or significant history of drug or alcohol abuse within 6 months of screening.\n12. Acute pulmonary embolism within 90 days of screening.\n13. Participation in pulmonary rehabilitation within 90 days of screening.\n14. Prior or concurrent use of any investigation drug\u002Fdevice\u002Ftherapy or participation in any investigational study with therapeutic intent within 30 days or 5 half-lives, whichever is longer before the first dose of the IP.\n15. BMI ≥40 kg\u002Fm2.\n16. Uncontrolled hypertension as evidenced by systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg during the screening period. Subjects who fail screening due to high blood pressure can be re-screened once, after their antihypertensive medicines have been adjusted and doses have been stable for at least 4 weeks.\n17. Concomitant disease that confers a life expectancy of \\\u003C6 months at screening.\n18. The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with the study procedures and treatment of addiction or any other relevant medical or psychiatric conditions.\n19. High likelihood of lung transplantation (in the opinion of the Investigator) within 4 months after randomization.\n20. History of liver dysfunction, including subjects with moderate (Child-Pugh B) or severe (Child Pugh C) impairment or disordered coagulation.\n21. Female subjects who are pregnant or breastfeeding.\n22. Worse than mild untreated sleep apnea (5-14.9 events\u002Fhour). Treated sleep apnea is permitted.\n\n    Other Exclusions\n23. History of allergic or anaphylactic reaction to mirivadelgat or to any component of the excipient.\n24. Previous exposure to mirivadelgat.\n\n    Diagnostic Assessments\n25. The following laboratory parameters are excluded:\n\n    * Hemoglobin \\\u003C10 g\u002FdL (100 g\u002FL).\n    * White blood cells (WBC) \\\u003C3000\u002FµL (\\\u003C3000\u002Fmm3).\n    * Platelet count \\\u003C70,000\u002FµL (70,000\u002Fmm3).\n    * Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2 or evidence of acute kidney injury.",{"count":56,"type":22},126,[25],"The goal of this clinical trial is to see if mirivadelgat will work in patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs.\n\nResearchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being.\n\nParticipants will:\n\nTake mirivadelgat or a placebo once a day for 12 weeks\n\nVisit the clinic once every 4 weeks for checkups and tests\n\nReceive phone calls every one or two weeks to check on how things are going",[60],"Group 3 Pulmonary Hypertension","RECRUITING","2025-10-02",{"date":64,"type":39},"2025-10-06",{"date":66,"type":39},"2025-03-01",{"date":68,"type":22},"2028-08",{"name":45,"class":46},9,""]