[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Qilu Pharmaceutical (Hainan) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4},"100603616","phase-4-a-phase-iv-study-of-dimethyl-fumarate-enteric-coated-capsules-for-relapsing-multiple-sclerosis-rms-100603616",false,"NCT07138833","A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)","A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)","Inclusion Criteria:\n\n* Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)\n* At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening\n* Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening\n\nExclusion Criteria:\n\n* History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \\[excluding multiple sclerosis\\]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.\n* Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.\n* History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a \"Yes\" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \\>5 years prior to screening require investigator assessment of eligibility.","ALL","18 Years","65 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety\\] in \\[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).\n\nThe main questions it aims to answer are:\n\n\\[Question 1\\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\n\\[Question 2\\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\nParticipants will:\n\nEligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.\n\nThe annualized relapse rate (ARR) at Week 48 will be observed.",[27],"Relapsing Multiple Sclerosis","NOT_YET_RECRUITING","2025-08-17",{"date":31,"type":32},"2025-08-24","ACTUAL",{"date":34,"type":21},"2025-09",{"date":36,"type":21},"2028-08",{"name":38,"class":39},"Qilu Pharmaceutical (Hainan) Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100587228","phase-1-a-study-of-qlm2011-in-subjects-with-advanced-solid-tumors-100587228","NCT06925659","A Study of QLM2011 in Subjects With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of QLM2011 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥18, ≤80 years, no gender limitation；\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable for the patient；\n* At least one measurable lesion as per RECIST version 1.1；\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；\n* Life expectancy ≥3 months；\n* All subjects of reproductive potential must agree to use an effective method of contraception during the study and for 3 months after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy, targeted therapy， endocrine therapy, immunotherapy and other anti-tumor treatment within 28 days of the first dose of the study drug, 6 weeks for nitrosoureas or mitomycin C, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications.\n* Uncontrolled or clinically symptomatic serous cavity effusions (e.g., pericardial effusion, pleural effusion, ascites, etc.) requiring repeated puncture drainage or medical intervention.\n* Toxicity from prior antitumor therapy has not recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE v5.0) (exceptions include alopecia, peripheral neuropathy, isolated laboratory abnormalities, or other toxicities deemed by the investigator to pose no safety risk).\n* Have a history of other malignant tumors within 3 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma or squamous cell carcinoma of the skin that has received radical treatment;","80 Years",{"count":49,"type":21},172,[51],"PHASE1","This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The purposeaim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of QLM2011 in patients with advanced solid tumors.",[54],"Advanced Solid Tumors","2025-04-14",{"date":57,"type":32},"2025-04-17",{"date":59,"type":21},"2025-05",{"date":61,"type":21},"2027-02",{"name":38,"class":39},""]