Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
NCT ID: NCT03993262
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2020-05-13
2026-12-31
Brief Summary
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There 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.
The 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.
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Detailed Description
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Therefore, we need a specific therapy aiming at the antibody-producing plasma cells.
Bortezomib is a proteasome inhibitor which interferes with NF-kB (nuclear factor kB) and the ubiquitin proteasome signaling pathway. Bortezomib acts preferably on cells with high protein synthesis - like plasma cells - and induces cell death in these cells. Bortezomib is used since more than a decade in chemotherapy of the multiple myeloma. Additionally, it is reported for systemic autoimmune diseases like lupus erythematodes that bortezomib leads to a depletion of plasma cells and therefore reduces the number of pathogenic antibodies and improves clinical outcome. The therapeutic potential of bortezomib for NMDAR encephalitis is described in a first case series with 5 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Interventional
1 to 3 cycles Bortezomib with 1,3mg/m2 body surface s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Bortezomib
1 to 3 cycles Bortezomib with 1,3mg/m2 body surface s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Placebo
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Placebo
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Interventions
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Bortezomib
1 to 3 cycles Bortezomib with 1,3mg/m2 body surface s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Placebo
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pretreatment with rituximab
* Age ≥18 years
* signed informed consent
* Women of childbearing potential (up to 2 years after menopause): negative pregnancy test
Exclusion Criteria
* acute infiltrative pulmonary and pericardial disease
* malignant tumor under current chemotherapy
* Simultaneous participation in another intervention study
* Previous participation in this study
* Known hypersensitivity to an ingredient of the investigational product
* Continued therapy with glucocorticoids / rituximab during the study duration (last dose must be administered before the first dose of the investigational product)
18 Years
ALL
No
Sponsors
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Federal Ministry of Education and Reserach (BMBF)
UNKNOWN
Jena University Hospital
OTHER
Responsible Party
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Christian Geis
Prof. Dr. med.
Principal Investigators
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Christian Geis, Prof.
Role: STUDY_DIRECTOR
University Hospital Jena
Locations
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Ludwig-Maximilians-Universität München, Klinikum Großhadern
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie
Jena, Germany, Germany
Medizinische Hochschule Hannover
Hanover, Niedersachen, Germany
Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
Berlin, , Germany
Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie
Bochum, , Germany
University Hospital Düsseldorf, Clinic for Neurology
Düsseldorf, , Germany
Universitätsklinikum Erlangen, Neurologische Klinik
Erlangen, , Germany
Universitätsklinikum Essen (AöR), Klinik für Neurologie
Essen, , Germany
University Hospital Frankfurt (Main), Clinic for Neurology
Frankfurt, , Germany
Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie
Göttingen, , Germany
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
Greifswald, , Germany
Klinik für Neurologie UKSH, Campus Kiel
Kiel, , Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
Leipzig, , Germany
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, , Germany
Universitätsklinikum Münster Klinik für Neurologie
Münster, , Germany
Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz
Ulm, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Wickel J, Chung HY, Platzer S, Lehmann T, Pruss H, Leypoldt F, Gunther A, Scherag A, Geis C; GENERATE Study Group. Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis. Trials. 2020 Jul 8;21(1):625. doi: 10.1186/s13063-020-04516-7.
Other Identifiers
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2024-514494-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
2019-001423-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DRKS00017497
Identifier Type: REGISTRY
Identifier Source: secondary_id
01GM1908E
Identifier Type: REGISTRY
Identifier Source: secondary_id
ZKSJ0120
Identifier Type: -
Identifier Source: org_study_id
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