Evaluating Bortezomib for Severe Autoimmune Encephalitis
A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
This study is testing if bortezomib can help people with severe autoimmune encephalitis feel better by targeting the cells that produce harmful antibodies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Drugs / interventions | rituximab, chemotherapy, cyclophosphamide |
| Locations | 17 sites (München, Bavaria and 16 other locations) |
| Trial ID | NCT03993262 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the efficacy and safety of bortezomib, a proteasome inhibitor, in patients diagnosed with severe autoimmune encephalitis characterized by autoantibodies against neuronal surface proteins. Currently, there are no specific therapies for this condition, and existing treatments often provide insufficient relief. The study will involve administering bortezomib to target the antibody-producing plasma cells, potentially leading to improved clinical outcomes. Participants will be monitored for both efficacy and safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with clinically diagnosed severe autoimmune encephalitis and detectable autoantibodies.
Not a fit: Patients who are pregnant, breastfeeding, or have certain acute diseases or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted therapy option for patients suffering from severe autoimmune encephalitis.
How similar studies have performed: While bortezomib has shown promise in small case series for similar conditions, this approach is still considered novel for treating autoimmune encephalitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and / or serum * Pretreatment with rituximab * Age ≥18 years * signed informed consent * Women of childbearing potential (up to 2 years after menopause): negative pregnancy test Exclusion Criteria: * pregnancy/breast-feeding * 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)
Where this trial is running
München, Bavaria and 16 other locations
- Ludwig-Maximilians-Universität München, Klinikum Großhadern — München, Bavaria, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany (Recruiting)
- Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie — Jena, Germany, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hanover, Niedersachen, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie — Berlin, Germany (Recruiting)
- Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie — Bochum, Germany (Recruiting)
- University Hospital Düsseldorf, Clinic for Neurology — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Erlangen, Neurologische Klinik — Erlangen, Germany (Recruiting)
- Universitätsklinikum Essen (AöR), Klinik für Neurologie — Essen, Germany (Recruiting)
- University Hospital Frankfurt (Main), Clinic for Neurology — Frankfurt, Germany (Recruiting)
- Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie — Göttingen, Germany (Recruiting)
- Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie — Greifswald, Germany (Recruiting)
- Klinik für Neurologie UKSH, Campus Kiel — Kiel, Germany (Recruiting)
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie — Leipzig, Germany (Recruiting)
- Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie — Mainz, Germany (Recruiting)
- Universitätsklinikum Münster Klinik für Neurologie — Münster, Germany (Recruiting)
- Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz — Ulm, Germany (Recruiting)
Study contacts
- Study coordinator: Christian Geis, Prof.
- Email: Christian.Geis@med.uni-jena.de
- Phone: +49 (0) 3641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.