Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03993262

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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

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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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Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis | DecenTrialz