[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-asthma":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,71,95,132,162,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100621566","phase-3-a-phase-iii-study-of-cm326-in-subjects-with-moderate-to-severe-asthma-100621566",false,"NCT07372287","A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma","A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma","Inclusion Criteria:\n\n1. Understand the study and voluntarily sign the informed consent form.\n2. Age ≥18 and ≤80 years old, male or female, weight ≥40 kg.\n3. The subject has been diagnosed with asthma for at least 1 year.\n4. Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value.\n5. A positive bronchodilation test within 24 months before informed consent or at screening.\n6. The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LAMA, LTRA, Oral corticosteroids, theophylline, for at least 3 months before signing the informed consent, and maintained stable treatment regimen and dosage for at least 1 month before signing the informed consent.\n7. Asthma Control Questionnaire-5 (ACQ-6) score ≥1.5.\n8. Subjects must have experienced at least one severe asthma exacerbation event within 12 months before informed consent, and have not experienced a severe asthma exacerbation event within 30 days before informed consent.\n9. ≥ 80% compliance with usual asthma controller therapy in subjects during the screening phase\n10. Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Chronic obstructive pulmonary disease (COPD) without asthma or other lung disease that may impair lung function, as judged by the investigator.\n2. Have systemic diseases other than asthma that result in an elevated peripheral blood eosinophil count or other diseases such as helminth parasitic infections for which standard treatment is not received or does not respond.\n3. Prior autoimmune disease or inflammatory treatment with biologic agents\u002Fsystemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.\n4. Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has resolved; or the presence of unusual frequent, recurrent, or prolonged infections.\n5. History of malignancy.\n6. The presence of any severe and\u002For uncontrolled medical condition that in the judgment of the investigator may affect the evaluation of the drug, including but not limited to: severe neurological disease, history of severe mental disorder, diabetes mellitus poorly controlled by intensive treatment.\n7. Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.\n8. A history of severe cardiovascular disease or clinically significant abnormalities identified by 12-lead electrocardiogram (ECG) during the screening phase.\n9. Major surgery within 8 weeks prior to informed consent requiring general anesthesia or hospitalization for \\> 1 day .\n10. Received biological agents with the same therapeutic purpose within 4 months or 5 half-lives (whichever is longer) before signing the informed consent.\n11. Have been enrolled in a clinical trial of any drug or medical device within 3 months before signing informed consent, or are within the follow-up period of a clinical study or the five half-lives of the trial drug (whichever is longer) before signing informed consent.\n12. Received immune globulin or blood products within 30 days before informed consent.\n13. Subjects treated with systemic corticosteroids other than for the treatment of asthma from 8 weeks before signing the informed consent to the date of randomization.\n14. Received live or attenuated vaccine within 3 months before informed consent.\n15. Initiation of desensitization therapy within 3 months before informed consent.\n16. Underwent bronchial thermoplasty within 12 months before informed consent.\n17. Current smokers or former smokers who quit smoking less than 6 months or former smokers who quit smoking more than 6 months with a smoking history of more than 10 pack-years.\n18. At screening, any infectious disease screening indicator meets one of the following criteria: a. HBsAg positive b. HBsAg negative , HBcAb positive, HBV DNA exceed the lower limit of quantitation (LLOQ) or 1000 copies\u002FmL (500 IU\u002FmL)(whichever is lower) c. HCV antibody positive, HCV RNA exceed the LLOQ or 1000 copies\u002FmL(whichever is lowerd). d.HIV antibody positive. e.Treponema pallidum antibody positive\n19. At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 × upper limit of normal (ULN), or serum creatinine (Cr) \\> 1.5 × ULN.\n20. Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock.\n21. Subjects who have used heavy alcohol within 3 months before screening.\n22. History of drug abuse within 5 years before signing informed consent.\n23. Females with a positive pregnancy test, pregnant females, or lactating females.\n24. The investigator considers that there are any conditions that may prevent the subject from completing the study.","ALL","18 Years","80 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma.\n\nThe study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.",[27],"Moderate to Severe Asthma","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":32},"2026-01-23",{"date":36,"type":21},"2029-03-31",{"name":38,"class":39},"CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100504677","phase-2-a-study-to-evaluate-the-efficacy-and-safety-study-of-povorcitinib-in-participants-with-inadequately-controlled-moderate-to-severe-asthma-100504677","NCT05851443","A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma","A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma","Inclusion Criteria:\n\n* Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.\n* Pre-BD FEV1 \\\u003C 80% predicted according to central over read value at Visit 2.\n* Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1.\n* At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening\n* ACQ-6 ≥ 1.5 at screening.\n\nExclusion Criteria:\n\n* Maintenance use of asthma controllers other than ICS-LABA.\n* Have undergone bronchial thermoplasty.\n* Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.\n* Women who are pregnant (or who are considering pregnancy) or breastfeeding.\n* Current conditions or history of other diseases, as follows:\n* Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.\n* Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.\n* Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.\n* Recipient of an organ transplant that requires continued immunosuppression.\n* Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).\n* Any malignancies or history of malignancies.\n* Chronic or recurrent infectious disease.\n* Receipt of any biologic drugs used for asthma \\\u003C 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening","65 Years",{"count":50,"type":21},240,[52],"PHASE2","The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function",[27],[56,57,58,59,60],"Asthma","Moderate to Severe","INCB54707","Povorcitinib","ICS-LABA","2026-04-10",{"date":63,"type":32},"2026-04-14",{"date":65,"type":32},"2023-07-11",{"date":67,"type":21},"2027-01-31",{"name":69,"class":39},"Incyte Corporation",83,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100623965","phase-2-phase-ii-trial-of-rc1416-injection-in-asthma-100623965","NCT07403487","Phase II Trial of RC1416 Injection in Asthma","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of RC1416 Injection in Adult Patients With Moderate to Severe Asthma","Inclusion Criteria:\n\n* Male or female aged 18 and 75 years.\n* Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines.\n* Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline.\n* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits.\n* Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits.\n* Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening.\n* Positive bronchodilator reversibility test.\n\nExclusion Criteria:\n\n* Individuals with a known history of allergy to the investigational product or its excipients.\n* Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function .\n* Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing.\n* Used systemic corticosteroids within 1 month prior to screening.\n* Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing.\n* Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening.\n* Underwent major surgery within 8 weeks prior to screening or plans to undergo major surgery during the study period.\n* With a history of malignancy within the past 5 years .\n* Active or incompletely treated tuberculosis\n* Used biologic\u002Fsystemic immunosuppressant\u002Fimmunomodulators within 12 weeks or 5 half-lives prior to screening.\n* Diagnosed active parasitic infection; suspected parasitic infection or high risk of infection.\n* Abnormal 12-lead electrocardiogram (ECG) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial","75 Years",{"count":80,"type":21},195,[52],"This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.",[27],"NOT_YET_RECRUITING","2026-02-04",{"date":87,"type":32},"2026-02-11",{"date":89,"type":21},"2026-03-10",{"date":91,"type":21},"2028-02-28",{"name":93,"class":39},"Nanjing RegeneCore Biotech Co., Ltd.",45,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":5},"100611479","phase-4-chest-a-collaboration-with-community-health-centers-to-implement-smart-for-asthma-100611479","NCT07241117","CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma","CHEST","The study population can be viewed from the cluster (clinic), clinician, staff, or patient level.\n\nAt the cluster (clinic) level: To be eligible to participate in this study, a cluster (clinic) must meet all the following criteria:\n\n1. Active participation in the St. Louis Integrated Health Center Network for Community Academic Partnerships.\n2. Employment of at least 3 clinicians who commonly manage adult asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).\n3. Data provided to Azara for data queries, and\n4. Willing and able to receive all components of the SMART implementation bundle (i.e., initial educational outreach visit, ongoing practice facilitation\u002Fsupervision, audit \\& feedback, and provision of education of patient-level education aides and SMART asthma action plans and monthly operations committee meetings).\n\nAt the clinician\u002Fclinical staff level:\n\nTo be eligible to participate in this study, a clinician\u002Fclinical staff member must meet all of the following criteria:\n\n1. Provision of a signed and dated informed consent form.\n2. Current state licenses of physician, assistant physician, nurse practitioner, or physician assistant.\n3. Regularly cares for adults with asthma (which may include those trained in family medicine, internal medicine, obstetrics\u002Fgynecology, and\u002For specialty medicine).\n4. Willing and able to integrate the SMART implementation bundle into their practice.\n5. Willing and able to participate for the entire duration of the study, including the pre-implementation, active implementation, and post-implementation periods.\n6. Willing to provide data on prescribing patterns and asthma patient outcomes for the duration of the study.\n\nAt the patient level:\n\nTo be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Age ≥12 years old\n2. Diagnosis of asthma, of any severity, coded (i.e., International Classification of Diseases \\[ICD\\]-10-CM: J45\\*\\*).\n3. The patient has had ≥2 asthma exacerbations in the last year during which systemic corticosteroids were prescribed, and\u002For the encounter contains an active prescription for an inhaler that is congruent with medium-dose (or higher) maintenance inhaled corticosteroids (ICS) inhalers or low-dose (or higher) ICS-long-acting β-agonist (LABA) inhalers with concomitant reliever short-acting β-agonist inhalers.","12 Years",{"count":104,"type":21},2000,[106],"PHASE4","Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy).\n\nThe investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers. The investigators will roll out these resources in stages across clinics. The study will measure how well the program helps clinicians prescribe SMART therapy and whether it reduces asthma exacerbations in patients.",[27],[110,111,112,100,113,114,115,116,117,118,119,120,121],"asthma","SMART","moderate to severe asthma","CHEST asthma study","asthma study","asthma action plan","implementation science","hybrid cluster","community health centers","MART","single maintenance and reliever therapy","maintenance and reliever therapy","2026-01-15",{"date":124,"type":32},"2026-01-16",{"date":126,"type":32},"2026-01-06",{"date":128,"type":21},"2028-11-15",{"name":130,"class":131},"Washington University School of Medicine","OTHER",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100607667","phase-2-effect-of-linvemastat-in-patients-with-partially-controlled-asthma-symmponia-100607667","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","85 Years",{"count":142,"type":21},135,[52],"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.",[146,147,148],"Asthma (Diagnosis)","Pulmonary Function","Moderate-to-Severe Asthma",[150,151,152],"central spirometry","type-2 (T2) high asthma","asthma management","2025-10-15",{"date":155,"type":32},"2025-10-20",{"date":157,"type":21},"2026-01-01",{"date":159,"type":21},"2027-09-01",{"name":161,"class":39},"Foresee Pharmaceuticals Co., Ltd.",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100545694","phase-4-leveraging-pharmacogenomics-in-asthma-for-predication-mechanism-and-endotyping-100545694","NCT06385236","Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping","EPIPHANY","Inclusion Criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Stable asthma medications: No change in asthma medications for the past 2 months:\n\n  1. Use of medium or high dose inhaled corticosteroids (ICS) AND\n  2. Use of an additional asthma controller medication.\n* Baseline poor or uncontrolled asthma.\n* Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence).\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Current participation in an interventional trial (e.g. drugs, diets, etc.).\n* Currently on an asthma biologic or having been on biologic within 3 months of screening.\n* Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).\n* Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.\n* Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.\n* Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).\n* Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy.\n* Underwent a bronchial thermoplasty within the last two years.\n* Born before 30 weeks of gestation.\n* Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mm\u002FHg or diastolic blood pressure \\> 100 mm\u002FHg.\n* History of malignancy except non-melanoma skin cancer within the last five years.\n* History of smoking:\n\n  1. If \\\u003C45 years old: Smoked for ≥5 pack-years\\*\n  2. If ≥45 years old: Smoked ≥ 10 pack years.\n* Active use of any inhalant \\>1 time per month in the past year.\n* Substance abuse within the last year.\n* Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation.\n* Requirement for daily systemic corticosteroids at the time of screening.\n* Respiratory infection within 1 month of screening.\n* Intubation for asthma in the last 12 months.\n* Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.\n* BMI \\> 38.\n* Allergic to any of the drugs, biologics or chemicals used in this study.",{"count":170,"type":21},120,[106],"In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.\n\nBy evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment.",[27],[56],"2024-08-16",{"date":177,"type":32},"2024-08-19",{"date":179,"type":32},"2024-02-19",{"date":181,"type":21},"2028-01-31",{"name":183,"class":131},"University of California, San Diego",3,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":78,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":40},"100497729","phase-2-a-study-of-cm310-in-subjects-with-moderate-to-severe-asthma-100497729","NCT05761028","A Study of CM310 in Subjects With Moderate to Severe Asthma","A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ\u002FⅢ Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma","Inclusion Criteria:\n\n1. Have the ability to understand the study and voluntarily sign the informed consent form.\n2. Age ≥12 and ≤75 years old, male or female, weight ≥40 kg.\n3. The subject has been diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of GINA 2022.\n4. Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits (V1 and V2).\n5. A positive bronchodilation test (≥12% increase in the FEV1 post-bronchodilator and an absolute FEV1 increase of ≥200 mL) within 24 months before consent or at screening.\n6. The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LAMA, LTRA, theophylline, for at least 3 months before signing the informed consent, and maintained stable treatment regimen and dosage for at least 1 month before signing the informed consent.\n7. Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits (V1 and V2).\n8. Subjects must have experienced at least one severe asthma exacerbation event within 12 months before consent, and have not experienced a severe asthma exacerbation event within 1 month before consent, with at least one severe asthma exacerbation event occurring during treatment with medium-to-high dose ICS.\n9. Subjects (including partners) have no plans to have children and voluntarily use highly effective contraception within 3 months after the last dose of study drug from the date of signing the informed consent.\n\nExclusion Criteria:\n\n1. Received biological agents with the same therapeutic purpose within 6 months before signing the informed consent.\n2. Prior autoimmune disease or inflammatory treatment with biologic agents\u002Fsystemic immunosuppressive agents within 8 weeks or 5 half- lives (whichever is longer) prior to informed consent.\n3. Received immune globulin or blood products within 30 days before informed consent.\n4. Subjects treated with systemic corticosteroids (except for topical, ophthalmic, or intranasal corticosteroids) from 4 weeks before signing the informed consent to the date of randomization.\n5. Received live or attenuated vaccine within 3 months before informed consent signing or planned to receive live or attenuated vaccine during the study period.\n6. Initiation of desensitization therapy within 3 months before informed consent.\n7. Underwent bronchial thermoplasty within 12 months before informed consent.\n8. Current smokers or former smokers who quit smoking less than 6 months or former smokers who quit smoking more than 6 months with a smoking history of more than 10 pack-years.\n9. Chronic obstructive pulmonary disease (COPD) or other lung disease that may impair lung function, as judged by the investigator.\n10. Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.\n11. Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has resolved; Or the presence of unusual frequent, recurrent, or prolonged infections.\n12. History of malignancy: subjects with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible to enter the study if they have completed curative treatment for at least 12 months before signing the informed consent. Subjects with other malignancies are allowed to enter the study if they have completed curative treatment for at least 5 years before signing the informed consent.\n13. The presence of any severe and\u002For uncontrolled medical condition that in the judgment of the investigator may affect the evaluation of the drug, including but not limited to: severe neurological disease, history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation, or persistent arrhythmia.\n14. Major surgery within 8 weeks prior to informed consent or planned surgery requiring general anesthesia or hospitalization for \\> 1 day during the study period.\n15. Fertile women with positive pregnancy test results during screening; Pregnant or lactating women.\n16. Positive screening serologic test for HIV or treponema pallidum.\n17. Chronic hepatitis B virus or hepatitis C virus infection.\n18. Subjects with abnormal liver and kidney function, such as aspartate aminotransferase or alanine aminotransferase\\>3 × ULN, or serum creatinine\\>1.5 × ULN.\n19. Have systemic diseases other than asthma that result in an elevated peripheral blood eosinophil count or other diseases such as helminth parasitic infections for which standard treatment is not received or does not respond.\n20. Allergy or intolerance to components of CM310 injection or placebo or history of severe drug allergy or anaphylactic shock.\n21. Have been enrolled in a clinical trial of any drug or medical device within 3 months before signing informed consent, or are within the follow-up period of a clinical study or the five half-lives of the trial drug (whichever is longer) before signing informed consent.\n22. Subjects who have used heavy alcohol within 3 months before screening.\n23. History of drug abuse within 5 years before signing informed consent.\n24. The investigator considers that there are any conditions that may prevent the subject from completing the study or present a significant risk to the subject or other factors that may reduce the likelihood of enrollment.",{"count":193,"type":21},600,[52,24],"This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ\u002FⅢ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma.\n\nThe study consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 4-week safety follow-up period.",[27],"2023-12-14",{"date":199,"type":32},"2023-12-15",{"date":201,"type":32},"2023-04-28",{"date":203,"type":21},"2032-05",{"name":205,"class":39},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd."]