[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":42,"responsibleParty":44,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":42,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":42,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":42,"overallStatus":67,"whyStopped":42,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":42},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inebilizumab with Rapid Steroid Tapering group","EXPERIMENTAL","Participants receive:\n\n1. Acute-phase: Methylprednisolone 1.0g IV daily (Days 1-5)\n2. Maintenance-phase:\n\n   * Day 6: Prednisone 60mg po daily + Inebilizumab 300mg IV\n   * Day 20: Second inebilizumab 300mg IV + Prednisone reduced to 60mg po every other day\n3. Steroid tapering schedule:Day 34→30mg EOD → Day 48→15mg EOD → Day 62→10mg EOD → Day 76→5mg EOD → Day 90→Discontinue\n4. Long-term: Third inebilizumab 300mg IV at Week 24",[13],"Drug: Inebilizumab + Rapid Steroid Tapering group",{"label":15,"type":16,"description":17,"interventionNames":18},"Inebilizumab with Standard Steroid Tapering group","ACTIVE_COMPARATOR","Participants receive:\n\n1. Acute-phase (Days 1-5):Methylprednisolone 1.0g IV daily\n2. Maintenance-phase:\n\n   * Day 6: Prednisone 60mg po daily +First inebilizumab 300mg IV\n   * Day 20: Second inebilizumab 300mg IV+Continue prednisone 60mg po daily until Day 34\n3. Steroid Tapering Schedule:\n\n   Day 34→60mg EOD → Day 62→30mg EOD → Day 90→15mg EOD → Day 118→10mg EOD → Day 146→5mg EOD → Day 174→Discontinue\n4. Long-term: Third inebilizumab 300mg IV at Week 24",[19],"Drug: Inebilizumab + Standard Steroid Tapering group",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Inebilizumab + Rapid Steroid Tapering group","Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \\& Tapering:Day 6-19: 60 mg daily；Day 20: 60 mg every other day (EOD)\n\n；Day 34: 30 mg EOD → Day 48: 15 mg EOD → Day 62: 10 mg EOD → Day 76: 5 mg EOD → Day 90: Discontinue Route: Oral",[9],[27],"Inebilizumab with rapid glucocorticoid taper group",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Inebilizumab + Standard Steroid Tapering group","Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \\& Tapering:Day 6-34: 60 mg daily;Day 34: 60 mg EOD → Day 62: 30 mg EOD → Day 90: 15 mg EOD → Day 118: 10 mg EOD → Day 146: 5 mg EOD → Day 174:Discontinue; Route: Oral",[15],[33],"Inebilizumab with standard glucocorticoid taper group",[35],{"name":36,"affiliation":5,"role":37},"Xu Zhang, Bachelor","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","0086-13587688130",null,"drzhangxu@live.cn",{"type":45,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100605236","inectolizumab-with-steroid-optimization-in-newly-treated-nmosd-100605236",false,"NCT07159893","Inectolizumab With Steroid Optimization in Newly Treated NMOSD","Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease","Inclusion Criteria:\n\n* Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and are AQP4-IgG positive, with a first-attack episode;\n* Male or female,age \\>=18 and \\\u003C=65 years old;\n* EDSS score ≤ 7.5;\n* Female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must use effective contraception throughout the study period;\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Laboratory abnormalities include: (white blood cell count \\\u003C 3×10⁹\u002FL), (neutrophils \\\u003C 1.5×10⁹\u002FL), (hemoglobin \\\u003C 85 g\u002FL), (platelet count \\\u003C 80×10⁹\u002FL), (serum creatinine \\> 1.5×ULN), (total bilirubin \\> 1.5×ULN), (AST (GOT) \\> 3×ULN), (ALT (GPT) \\> 3×ULN), (alkaline phosphatase \\> 2×ULN).\n* Patients currently suffering from active hepatitis or with a history of severe liver disease are ineligible. Based on the following serological test results for HBsAg, anti-HBc antibodies, and anti-HBs antibodies, there is evidence of hepatitis B virus (HBV) infection: Patients with positive HBsAg should be excluded. For patients with negative HBsAg but positive anti-HBc antibodies, regardless of whether anti-HBs antibodies are positive or negative, HBV-DNA testing is required to determine their status: If HBV-DNA is positive, the patient should be excluded; if HBV-DNA is negative, the patient may be eligible for the trial.\n* Patients with other chronic active immune system diseases, or those with stable conditions but requiring glucocorticoid therapy, are excluded, except for neuromyelitis optica spectrum disorder (NMOSD). Examples include rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic immunodeficiency, or drug-induced immunodeficiency. Patients with only positive autoantibodies but without clinical manifestations may be eligible for the trial.\n* Pregnant women, breastfeeding women, and patients who plan to conceive during the trial period.\n* Allergic reactions: Patients with a history of allergies to contrast agents administered via the parenteral route or to human-derived biological products.\n* Patients who received a live vaccine, except for the herpes zoster vaccine, within 28 days prior to randomization.\n* Patients who have used rituximab or other monoclonal antibodies within 6 months prior to randomization\n* Patients who have received intravenous immunoglobulin (IVIG) within 28 days prior to randomization.\n* Patients who have undergone hematopoietic stem cell transplantation or lymphocyte irradiation before randomization.\n* Patients who have used immunosuppressive agents such as azathioprine (Azathioprine, AZA, half-life t1\u002F2 = 6 hrs), mycophenolate mofetil (Mycophenolate Mofetil, t1\u002F2 = 16 hrs), leflunomide (Leflunomide, LEF, t1\u002F2 = 14.7 hrs), tacrolimus (Tacrolimus, t1\u002F2 = 43 hrs), teriflunomide (Teriflunomide, t1\u002F2 = 18 days), cyclosporine (Cyclosporin, CsA, t1\u002F2 = 27 hrs), methotrexate (Methotrexate, MTX, t1\u002F2 = 14 hrs), mitoxantrone (Mitoxantrone, NVT, t1\u002F2 = 37 hrs), and cyclophosphamide (Cyclophosphamide, CTX, t1\u002F2 = 6 hrs) before randomization are excluded. Except for leflunomide and teriflunomide, patients can be enrolled if the washout period exceeds five half-lives. For leflunomide and teriflunomide, patients need to undergo cholestyramine washout as follows: take 8 grams of cholestyramine orally three times daily for 11 days. If the 8-gram dose is not tolerated, it can be changed to 4 grams per dose, with the same frequency and duration.\n* Patients who have received any investigational drug within 28 days or five half-lives of the trial drug (whichever is shorter) before randomization.\n* Patients with symptoms of severe mental illness who are clinically unable to co-operate;\n* Patients with malignant tumours.\n* Patients who have experienced any of the following events within 12 weeks prior to randomization: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) Class IV heart failure.\n* Patients with herpes zoster infection, positive for HCV antibodies, or positive for HIV antibodies during the screening period.\n* Patients who are unable to undergo magnetic resonance imaging (MRI) during the trial period.\n* Patients whom the investigator deems unsuitable for participation in the trial.","ALL","18 Years","65 Years",{"count":57,"type":58},25,"ESTIMATED","INTERVENTIONAL",[61],"NA","Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels.\n\nStudy Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.",[64,65,66],"Neuromyelitis Optica","Autoimmune Diseases","Demyelinating Autoimmune Diseases, CNS","NOT_YET_RECRUITING","2025-09-04",{"date":70,"type":71},"2025-09-08","ACTUAL",{"date":73,"type":58},"2025-09",{"date":75,"type":58},"2026-09",{"name":5,"class":6}]