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Lewerenz, PD Dr.","+49 731 500","63146","jan.lewerenz@uni-ulm.de",{"name":352,"role":37,"phone":353,"phoneExt":354,"email":355},"Mabule Senel, Dr.","+49 731 077","5265","makbule.senel@uni-ulm.de",{"type":357,"investigatorFullName":358,"investigatorTitle":359,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Christian Geis","Prof. Dr. med.",[361],{"name":362,"class":363},"Federal Ministry of Education and Reserach (BMBF)","UNKNOWN","100361984","phase-2-trial-to-evaluate-efficacy-and-safety-of-bortezomib-in-patients-with-severe-autoimmune-encephalitis-100361984",false,"NCT03993262","Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis","A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis","Generate-Boost","Inclusion Criteria:\n\n* Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and \u002F or serum\n* Pretreatment with rituximab\n* Age ≥18 years\n* signed informed consent\n* Women of childbearing potential (up to 2 years after menopause): negative pregnancy test\n\nExclusion Criteria:\n\n* pregnancy\u002Fbreast-feeding\n* acute infiltrative pulmonary and pericardial disease\n* malignant tumor under current chemotherapy\n* Simultaneous participation in another intervention study\n* Previous participation in this study\n* Known hypersensitivity to an ingredient of the investigational product\n* Continued therapy with glucocorticoids \u002F rituximab during the study duration (last dose must be administered before the first dose of the investigational product)","ALL","18 Years",{"count":375,"type":376},50,"ESTIMATED","INTERVENTIONAL",[379],"PHASE2","Autoimmune Encephalitis is a disorder of the central nervous system caused by bodily substances, called antibodies. Antibodies normally help the body to prevent infections. However, in this disorder, the antibodies turn against the body itself and especially against cells in the brain and disturb the normal brain function. They are therefore called autoantibodies.\n\nThere is no specific therapy for patients with autoimmune encephalitis so far. At the moment, the symptoms are treated with approved medications such as cortisone and immunotherapies also used in oncology. These therapies are unspecified and aim to reduce the number of autoantibodies and to contain the autoimmune process. In this trial we aim to test a new therapy option: in this therapy the body cells producing autoantibodies will be specifically targeted by a substance called bortezomib.\n\nThe trial addresses patients with severe autoimmune encephalitis. The aim of the trial is to evaluate the efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.",[382],"Autoimmune Encephalitis",[384,385,386,387,388,389],"autoimmune disease","autoimmune encephalitis","bortezomib","NMDAR","LGI1","encephalitis","2025-08-27",{"date":392,"type":393},"2025-09-04","ACTUAL",{"date":395,"type":393},"2020-05-13",{"date":397,"type":376},"2026-12-31",{"name":5,"class":6},17]