A PHASE-2B, DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE ACTIVITY AND SAFETY OF INEBILIZUMAB IN ANTI-NMDA RECEPTOR ENCEPHALITIS AND ASSESS MARKERS OF DISEASE (EXTINGUISH) - ExTINGUISH

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)0 个研究点目标入组 116 人开始时间: 2023年6月27日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Diagnosis of NMDAR encephalitis, defined by a subacute onset of change in mental status consistent with autoimmune encephalitis AND a positive cell-based assay for NMDAR immunoglobulin G antibody in the cerebrospinal fluid confirmed in study-specified laboratories, Willing to forego other immunomodulatory therapies (investigational or otherwise) for NMDAR encephalitis during the study, mRS of = 3 at the screening visit, indicating at least moderate disability, Participant must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 30 days prior to randomization (Day 1). In addition, participants must have received EITHER IVIg, at dose range between 1.2 and 2 g/kg OR Plasma exchange or plasmapheresis, with a minimum of 5 treatments

•Recurrence of previously treated NMDAR encephalitis within the last 5 years, or suspicion of symptomatic untreated NMDAR encephalitis of greater than 3 months duration at the time of screening, Receipt of any biologic B cell-depleting therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening, Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the investigational product, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk, Receipt of any of the following within 3 months prior to randomization: Natalizumab (Tysabri (r)), Cyclosporine, Methotrexate, Mitoxantrone, Cyclophosphamide, Azathioprine, Mycophenolate mofetil

发起方