Actively Recruiting
Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
Led by Jena University Hospital · Updated on 2025-09-04
50
Participants Needed
17
Research Sites
346 weeks
Total Duration
On this page
Sponsors
J
Jena University Hospital
Lead Sponsor
F
Federal Ministry of Education and Reserach (BMBF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed severe autoimmune encephalitis with autoantibodies to neuronal surface proteins in cerebrospinal fluid and/or serum
- Pretreatment with rituximab
- Age 18 years or older
- Signed informed consent
- Negative pregnancy test for women of childbearing potential (up to 2 years after menopause)
You will not qualify if you...
- Pregnancy or breastfeeding
- Acute infiltrative pulmonary or pericardial disease
- Malignant tumor under current chemotherapy
- Participation in another intervention study
- Previous participation in this study
- Known hypersensitivity to any ingredient of the study drug
- Continued therapy with glucocorticoids or rituximab during the study (last dose before study drug start)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Ludwig-Maximilians-Universität München, Klinikum Großhadern
München, Bavaria, Germany, 81377
Actively Recruiting
2
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
3
Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie
Jena, Germany, Germany, 07747
Actively Recruiting
4
Medizinische Hochschule Hannover
Hanover, Niedersachen, Germany, 30625
Actively Recruiting
5
Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
Berlin, Germany, 10117
Actively Recruiting
6
Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie
Bochum, Germany, 44791
Actively Recruiting
7
University Hospital Düsseldorf, Clinic for Neurology
Düsseldorf, Germany, 40225
Actively Recruiting
8
Universitätsklinikum Erlangen, Neurologische Klinik
Erlangen, Germany, 91054
Actively Recruiting
9
Universitätsklinikum Essen (AöR), Klinik für Neurologie
Essen, Germany, 45147
Actively Recruiting
10
University Hospital Frankfurt (Main), Clinic for Neurology
Frankfurt, Germany, 60528
Actively Recruiting
11
Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie
Göttingen, Germany, 37075
Actively Recruiting
12
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
Greifswald, Germany, 17475
Actively Recruiting
13
Klinik für Neurologie UKSH, Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
14
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
Leipzig, Germany, 04103
Actively Recruiting
15
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, Germany, 55131
Actively Recruiting
16
Universitätsklinikum Münster Klinik für Neurologie
Münster, Germany, 48149
Actively Recruiting
17
Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz
Ulm, Germany, 89081
Actively Recruiting
Research Team
C
Christian Geis, Prof.
CONTACT
J
Jonathan Wickel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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