Autoimmune EncephalitisPhase 2Generate-BoostNCT03993262
Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
A Phase 2 study testing Bortezomib in people with Autoimmune Encephalitis, run by Jena University Hospital at 17 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- Bortezomib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 17 sitesGermany
- Study dates
- 13 May 2020to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Germany17 sites, 17 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
Berlin, 10117
Harald Pruess, PD Dr., +49 30 450560 ext. 560, harald.pruess@charite.de
Peter Koertvelyessy, Dr., +49 30 450560 ext. 164, p.koertvelyessy@dzne.de
- Recruiting
Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie
Bochum, 44791
Ilya Ayzenberg, PD Dr., +49 234 509 ext. 6423, Ilya.Ayzenberg@ruhr-uni-bochum.de
Ruth Schneider, Dr., +49 234 509 ext. 6433, ruth.schneider@rub.de
- Recruiting
University Hospital Düsseldorf, Clinic for Neurology
Düsseldorf, 40225
Nico Melzer, PD Dr., +4921181 ext. 18978, Nico.Melzer@med.uni-duesseldorf.de
Sven G Meuth, Prof. Dr., +4921181 ext. 17880, SvenGuenther.Meuth@med.uni-duesseldorf.de
- Recruiting
Universitätsklinikum Erlangen, Neurologische Klinik
Erlangen, 91054
Veit Rothhammer, Prof. Dr., Veit.Rothhammer@uk-erlangen.de
Thanos Tsaktanis, Dr., Thanos.Tsaktanis@uk-erlangen.de
- Recruiting
Universitätsklinikum Essen (AöR), Klinik für Neurologie
Essen, 45147
Carlos Quesada, Dr., Carlos.Quesada@uk-essen.de
Refik Pul, Dr., Refik.Pul@uk-essen.de
- Recruiting
University Hospital Frankfurt (Main), Clinic for Neurology
Frankfurt, 60528
Felix Rosenow, Prof. Dr., +49696301 ext. 84521, rosenow@med.uni-frankfurt.de
Adam P Strzelczyk, Prof. Dr., +49696301 ext. 5852, AdamPeter.Strzelczyk@kgu.de
- Recruiting
Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie
Göttingen, 37075
Dirk Fitzner, Dr., +49 551 39 ext. 65593, d.fitzner@med.uni-goettingen.de
- Recruiting
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
Greifswald, 17475
Bernadette Gaida, Dr., bernadette.gaida@med.uni-greifswald.de
Felix von Podewils, Prof. Dr., Felix.vonPodewils@med.uni-greifswald.de
- Recruiting
Medizinische Hochschule Hannover
Hanover, Niedersachen, 30625
Kurt-Wolfram Suehs, PD Dr., +49511532 ext. 2495, Suehs.Kurt-Wolfram@mh-hannover.de
Martin Stangel, Prof., +49511532 ext. 6676, Stangel.Martin@mh-hannover.de
- Recruiting
Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie
Jena, Germany, 07747
Christian Geis, Prof., +49-3641 ext. -9323413, Christian.Geis@med.uni-jena.de
Jonathan Wickel, Dr., +49 3641 ext. 9323561, Jonathan.Wickel@med.uni-jena.de
- Recruiting
Klinik für Neurologie UKSH, Campus Kiel
Kiel, 24105
Frank Leypoldt, PD Dr., +49 431 500 ext. 16209, frank.leypoldt@uksh.de
Klarissa Stuerner, Dr., +49 431 500 ext. 23816, klarissa.stuerner@uksh.de
- Recruiting
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
Leipzig, 04103
Florian Then Berg, Prof. Dr., +49 341972 ext. 4320, Florian.ThenBergh@medizin.uni-leipzig.de
Lars-Malte Teusser, Dr., +49 341972 ext. 4320, lars-malte.teusser@medizin.uni-leipzig.de
- Recruiting
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, 55131
Stefan Bittner, Prof., +49 6131 17 ext. 2805, stefan.bittner@unimedizin-mainz.de
Felix Lüssi, PD Dr., +49 6131 17 ext. 5278, felix.luessi@unimedizin-mainz.de
- Recruiting
Ludwig-Maximilians-Universität München, Klinikum Großhadern
München, Bavaria, 81377
Tania Kümpfel, Prof., +49894400 ext. 74435, tania.kuempfel@med.uni-muenchen.de
Joachim Havla, Dr., +49894400 ext. 74435, joachim.havla@med.uni-muenchen.de
- Recruiting
Universitätsklinikum Münster Klinik für Neurologie
Münster, 48149
Oliver M Grauer, PD Dr., +49 251 8348 ext. 6814, OliverMartin.Grauer@ukmuenster.de
Stjepana Kovac, PD Dr., stjepana.kovac@ukmuenster.de
- Recruiting
Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz
Ulm, 89081
Jan Lewerenz, PD Dr., +49 731 500 ext. 63146, jan.lewerenz@uni-ulm.de
Mabule Senel, Dr., +49 731 077 ext. 5265, makbule.senel@uni-ulm.de
- Recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Claudia Sommer, Prof., +49931201 ext. 23763, sommer_c@ukw.de
Kathrin Doppler, PD Dr., +49931201 ext. 23787, doppler_K@ukw.de
About this study
Official title: A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
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.
Read the detailed description
Autoimmune encephalitis is characterized by autoantibodies against neuronal surface antigens like the NMDA (N-methyl-D-aspartate) receptor or LGI1 (Leucin-rich glioma inactivated protein 1). So far, no specific therapy exists for this disease. Actual treatment includes combination therapies aiming for a reduction of pathogenic antibodies and containing the autoimmune process. In first line, patients are treated with plasmapheresis and cortisone. In second line, Rituximab and/or cyclophosphamide are administered. The response to these treatments are, however, often delayed and insufficient.
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
- Autoimmune Encephalitis
- Being tested
- Bortezomib, Placebo
- Keywords
- autoimmune disease, autoimmune encephalitis, bortezomib, NMDAR, LGI1, encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Autoimmune Diseases, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
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)
PlaceboDrug
Also called isotonic NaCl solution
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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) Receives: Drug: Bortezomib |
| Placebo | Placebo comparator | 1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin-Score (mRS)
modified Rankin-Score from 0 = no symptoms to 6 = death
Measured: 17 weeks after first administration of the study drug
Secondary outcomes (18)
modified Rankin-Score (mRS)
modified Rankin-Score from 0 = no symptoms to 6 = death
Measured: 3, 6, 9 and 13 weeks after first administration of the study drug; GCS Score also 17 weeks after first administration of the study drug
Length of in-hospital stay / length of ICU stay
Number of days in hospital or on ICU for each patient from first administration of the study drug until 17 weeks after first administration of the study drug
Measured: until 17 weeks after first administration of the study drug
Immune response
Antibody titer (in serum and liquor) and cellular immune response (FACS analysis of liquor)
Measured: at study start and 17 weeks after first administration of the study drug
neurocognitive function assessed by Montreal Cognitive Assessment
total score of the Montreal Cognitive Assessment (MoCA) (0 to max. 30 points = best possible result)
Measured: at study start and 17 weeks after first administration of the study medication
neurocognitive function assessed by Mini-Mental Status Test
total score of the Mini-Mental Status Test (MMST) (0 to max 30 points = best possible result)
Measured: at study start and 17 weeks after first administration of the study medication
neurocognitive function assessed by Rey Auditory Verbal Learning Test
total score of the Rey Auditory Verbal Learning Test (RAVLT) (memory performance assessed by 3 word lists which are read to the patient and should be recalled and repeated by the patient; different proceeding for the 3 word lists)
Measured: at study start and 17 weeks after first administration of the study medication
neurocognitive function assessed by Neuropsychiatric Inventory Questionnaire
total score of the Neuropsychiatric Inventory Questionnaire (NPI) (0 = best score to max 36 (patient) or 60 (caregiver)
Measured: at study start and 17 weeks after first administration of the study medication
safety of Bortezomib regarding polyneuropathy, increase of liver enzymes and secondary infections
number of polyneuropathy cases, number of increased liver enzymes, number of secondary infections
Measured: until 17 weeks after first administration of the study drug
safety of Bortezomib regarding polyneuropathy
number of polyneuropathy cases
Measured: until 17 weeks after first administration of the study drug
safety of Bortezomib regarding increase of liver enzymes
number of increased liver enzyme values
Measured: until 17 weeks after first administration of the study drug
Secondary infections due to Bortezomib
number of secondary infections
Measured: until 17 weeks after first administration of the study drug
Hematotoxicity events due to Bortezomib
number of hematotoxicity events
Measured: until 17 weeks after first administration of the study drug
Gastrointestinal toxicity due to Bortezomib
number of gastrointestinal toxicity events
Measured: until 17 weeks after first administration of the study drug
total Glasgow Coma Scale (GCS)
GCS from 3 to 15 points (sum of 3 subscores eye response (1 to 4 points), motor response (1 to 6 points), verbal response (1 to 5 points); highest score = best score; 1= worst score)
Measured: 3, 6, 9, 13 and 17 weeks after first administration of the study drug
Destruction marker UCH-L1 (Ubiquitin carboxy-terminal hydrolase L1) in serum and liquor
Analysis of destruction marker UCH-L1 in serum and liquor
Measured: at baseline visit and 17 weeks after first administration of the study drug
Destruction marker Neurofilament light chain (in serum and liquor)
Analysis of destruction marker Neurofilament light chain in serum and liquor
Measured: at baseline visit and 17 weeks after first administration of the study drug
Destruction markers GFAP (glial fibrillary acidic protein) in serum and liquor
Analysis of destruction marker GFAP in serum and liquor
Measured: at baseline visit and 17 weeks after first administration of the study drug
Destruction marker TAU proteins in serum and liquor
Analysis of destruction marker TAU in serum and liquor
Measured: at baseline visit and 17 weeks after first administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start13 May 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization will be done centrally and stratified by site. Block randomization of variable block sizes will be used.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Education and Reserach (BMBF)
- Responsible party
- Principal investigator, Christian Geis, Jena University Hospital
- Investigators
- Christian Geis, Prof., Study director, University Hospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993262
- Sponsor's protocol ID
- ZKSJ0120
- Other IDs
- 2024-514494-21-00, 2019-001423-12, DRKS00017497, 01GM1908E, 2019
- Acronym
- Generate-Boost
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided in which way and which data exactly will be shared with other researchers.
Publications
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.
PubMed 32641101
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT03993262
- Acronym / sponsor ID
- Generate-Boost / ZKSJ0120
- Conditions
- Autoimmune Encephalitis
- Keywords
- autoimmune disease, autoimmune encephalitis, bortezomib, NMDAR, LGI1, encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Federal Ministry of Education and Reserach (BMBF)
- Study start
- 13 May 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autoimmune encephalitis is characterized by autoantibodies against neuronal surface antigens like the NMDA (N-methyl-D-aspartate) receptor or LGI1 (Leucin-rich glioma inactivated protein 1). So far, no specific therapy exists for this disease. Actual treatment includes combination therapies aiming for a reduction of pathogenic antibodies and containing the autoimmune process. In first line, patients are treated with plasmapheresis and cortisone. In second line, Rituximab and/or cyclophosphamide are administered. The response to these treatments are, however, often delayed and insufficient.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization will be done centrally and stratified by site. Block randomization of variable block sizes will be used.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: Bortezomib1 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 | Placebo comparator | Drug: Placebo1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib1 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) | Drug | Interventional |
| PlaceboAlso: isotonic NaCl solution1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle) | Drug | Placebo |
Primary outcome
modified Rankin-Score (mRS)
Time frame: 17 weeks after first administration of the study drug
modified Rankin-Score from 0 = no symptoms to 6 = death
18 secondary outcomes
modified Rankin-Score (mRS)
Time frame: 3, 6, 9 and 13 weeks after first administration of the study drug; GCS Score also 17 weeks after first administration of the study drug
Length of in-hospital stay / length of ICU stay
Time frame: until 17 weeks after first administration of the study drug
Immune response
Time frame: at study start and 17 weeks after first administration of the study drug
neurocognitive function assessed by Montreal Cognitive Assessment
Time frame: at study start and 17 weeks after first administration of the study medication
neurocognitive function assessed by Mini-Mental Status Test
Time frame: at study start and 17 weeks after first administration of the study medication
neurocognitive function assessed by Rey Auditory Verbal Learning Test
Time frame: at study start and 17 weeks after first administration of the study medication
neurocognitive function assessed by Neuropsychiatric Inventory Questionnaire
Time frame: at study start and 17 weeks after first administration of the study medication
safety of Bortezomib regarding polyneuropathy, increase of liver enzymes and secondary infections
Time frame: until 17 weeks after first administration of the study drug
safety of Bortezomib regarding polyneuropathy
Time frame: until 17 weeks after first administration of the study drug
safety of Bortezomib regarding increase of liver enzymes
Time frame: until 17 weeks after first administration of the study drug
Secondary infections due to Bortezomib
Time frame: until 17 weeks after first administration of the study drug
Hematotoxicity events due to Bortezomib
Time frame: until 17 weeks after first administration of the study drug
Gastrointestinal toxicity due to Bortezomib
Time frame: until 17 weeks after first administration of the study drug
total Glasgow Coma Scale (GCS)
Time frame: 3, 6, 9, 13 and 17 weeks after first administration of the study drug
Destruction marker UCH-L1 (Ubiquitin carboxy-terminal hydrolase L1) in serum and liquor
Time frame: at baseline visit and 17 weeks after first administration of the study drug
Destruction marker Neurofilament light chain (in serum and liquor)
Time frame: at baseline visit and 17 weeks after first administration of the study drug
Destruction markers GFAP (glial fibrillary acidic protein) in serum and liquor
Time frame: at baseline visit and 17 weeks after first administration of the study drug
Destruction marker TAU proteins in serum and liquor
Time frame: at baseline visit and 17 weeks after first administration of the study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 32641101Wickel 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.
- Individual participant dataSharing planned: Undecided. It is not yet decided in which way and which data exactly will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Geis, Prof. study director
University Hospital Jena
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib in people with Autoimmune Encephalitis, run by Jena University Hospital at 17 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Geis, Prof. (+49 (0) 3641 ext. 9323413, Christian.Geis@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin-Score (mRS) (time frame: 17 weeks after first administration of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.