Clinical trial • Phase II • Immunology|Neurology
BORTEZOMIB for Autoimmune encephalitis|Autoantibody-positive autoimmune encephalitis
Phase II trial of BORTEZOMIB for Autoimmune encephalitis|Autoantibody-positive autoimmune encephalitis.
Overview
- Trial Therapeutic Area
- Immunology|Neurology
- Trial Disease
- Autoimmune encephalitis|Autoantibody-positive autoimmune encephalitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 12-06-2024
- First CTIS Authorization Date
- 27-06-2024
Trial design
Randomised, saline (placebo) — solution for injection (saline). no dose or schedule for the comparator explicitly specified in the available data.-controlled Phase II trial in Germany.
- Randomised
- Yes
- Comparator
- Saline (placebo) — solution for injection (SALINE). No dose or schedule for the comparator explicitly specified in the available data.
- Target Sample Size
- 50
- Trial Duration For Participant
- 119
Eligibility
Recruits 50 Vulnerable population selected. Consent may be provided by the patient or, if the patient cannot write for motor reasons, by the patient "under witness"; alternatively consent may be provided by the legal representative (guardian) or the authorized representative. Specific subject information and informed consent forms for patient and representative are listed in the trial documents..
- Pregnancy Exclusion
- Potentially fertile patient (up to 2 years after menopause): negative pregnancy test
- Vulnerable Population
- Vulnerable population selected. Consent may be provided by the patient or, if the patient cannot write for motor reasons, by the patient "under witness"; alternatively consent may be provided by the legal representative (guardian) or the authorized representative. Specific subject information and informed consent forms for patient and representative are listed in the trial documents.
Inclusion criteria
- {"criterion_text":"- Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3)\n- Autoantibodies against neuronal surface proteins in cerebrospinal fluid or serum serum, detection must not be older than 4 weeks, calculated before randomization\n- Pre-treatment with rituximab\n- Age ≥ 18 years\n- Written informed consent of the patient or the patient “under witness” (if the patient cannot write for motor reasons) cannot write themselves) or the legal representative (=guardian) or the authorized representative\n- Potentially fertile patient (up to 2 years after menopause): negative pregnancy test"}
Exclusion criteria
- {"criterion_text":"- Lactation\n- Acute infiltrative lung disease\n- Acute infiltrative pericardial disease\n- Malignant tumor under ongoing or newly started chemotherapy\n- Concurrent participation in another intervention study\n- Previous participation in this study\n- Known hypersensitivity to any ingredient of the investigational product\n- Continued therapy with glucocorticoids/rituximab during the duration of the study (last administration must be completed before first administration of investigational product)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- mRS 17 weeks after first administration of the investigational product","definition_or_measurement_approach":"Modified Rankin Scale (mRS) score assessed 17 weeks after first administration of the investigational product"}
Secondary endpoints
- {"endpoint_text":"- mRS and GCS 3, 6, 9 and 13 weeks after first administration of the investigational product; GCS 17 weeks after first administration of the investigational product","definition_or_measurement_approach":"Modified Rankin Scale (mRS) and Glasgow Coma Scale (GCS) assessed at 3, 6, 9, 13 weeks; GCS also at 17 weeks after first administration"}
- {"endpoint_text":"- Length of stay in hospital/intensive care unit","definition_or_measurement_approach":"Duration of hospital and/or intensive care unit stay measured during the study period"}
- {"endpoint_text":"- Antibody titers and destruction markers (in serum and cerebrospinal fluid), cellular immune response (FACS, in cerebrospinal fluid) at the baseline visit and 17 weeks after first administration of the investigational product","definition_or_measurement_approach":"Laboratory measurement of antibody titers and destruction markers in serum and CSF; cellular immune response by FACS in CSF at baseline and 17 weeks"}
- {"endpoint_text":"- Neurocognitive function (MoCA, MMST, VLMT and NPI) at the baseline visit and 17 weeks after the first visit and 17 weeks after first administration of the investigational product","definition_or_measurement_approach":"Neurocognitive assessments using MoCA, MMST, VLMT and NPI at baseline and 17 weeks after first administration"}
- {"endpoint_text":"- Number of all (serious) adverse events within 17 weeks after the first 17 weeks after first administration of the investigational product","definition_or_measurement_approach":"Count and classification of adverse events (including serious adverse events) occurring within 17 weeks after first administration"}
- {"endpoint_text":"- Bortezomib safety with regard to polyneuropathy, increase in liver enzymes liver enzymes, hematotoxicity, gastrointestinal toxicity and secondary infections.","definition_or_measurement_approach":"Safety monitoring for polyneuropathy, liver enzyme elevations, hematotoxicity, GI toxicity and secondary infections as reported and graded during the study"}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 20
- Consent Approach
- Written informed consent required from the patient. If the patient cannot write for motor reasons, consent may be provided 'under witness'. Consent may alternatively be provided by the legal representative (guardian) or an authorized representative. Separate subject information and informed consent forms for patient and representative are included among trial documents. Languages of the consent documents are not specified in the available data.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 50
Germany
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 495
- Number Of Sites
- 17
- Number Of Participants
- 50
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Stefan Bittner
- Contact Person Email
- bittner@uni-mainz.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Frank Leypoldt
- Contact Person Email
- frank.leypoldt@uksh.de
- Site Name
- Ruhr University
- Department Name
- Clinic for Neurology
- Contact Person Name
- Ilya Ayzenberg
- Contact Person Email
- Ilya.Ayzenberg@rub.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Clinic for Neurology
- Contact Person Name
- Dirk Fitzner
- Contact Person Email
- sz-umg.sponsor-qm@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Nico Melzer
- Contact Person Email
- Nico.Melzer@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Claudia Sommer
- Contact Person Email
- sommer_c@ukw.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Tania Kuempfel
- Contact Person Email
- tania.kuempfel@med.uni-muenchen.de
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Bernadette Gaida
- Contact Person Email
- bernadette.gaida@med.uni-greifswald.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Christian Geis
- Contact Person Email
- christian.geis@med.uni-jena.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Veit Rothhammer
- Contact Person Email
- Veit.Rothhammer@uk-erlangen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Clinic for Neurology
- Contact Person Name
- Kurt-Wolfram Suehs
- Contact Person Email
- Suehs.Kurt-Wolfram@mh-hannover.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Harald Pruess
- Contact Person Email
- harald.pruess@charite.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Felix Rosenow
- Contact Person Email
- rosenow@med.uni-frankfurt.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Jan Lewerenz
- Contact Person Email
- Jan.Lewerenz@uniklinik-ulm.de
- Site Name
- Universitaet Leipzig
- Department Name
- Clinic for Neurology
- Contact Person Name
- Florian Then Bergh
- Contact Person Email
- Florian.ThenBergh@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Clinic for Neurology
- Contact Person Name
- Carlos Quesada
- Contact Person Email
- Carlos.Quesada@uk-essen.de
- Site Name
- Universitaet Muenster
- Department Name
- Clinic for Neurology
- Contact Person Name
- Stjepana Kovac
- Contact Person Email
- stjepana.kovac@ukmuenster.de
Sponsor
Primary sponsor
- Full Name
- Friedrich-Schiller-Universitaet Jena
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BORTEZOMIB
- Active Substance
- BORTEZOMIB
- Modality
- Small molecule
- Routes Of Administration
- PERCUTANEOUS USE
- Route
- PERCUTANEOUS USE
- Maximum Dose
- 1.3 mg/m2
- Investigational Product Name
- SALINE
- Active Substance
- SALINE
- Modality
- Other
- Routes Of Administration
- PERCUTANEOUS USE
- Route
- PERCUTANEOUS USE
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