A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis

Phase 1

• Conditions: autoimmune encephalitis; MedDRA version: 20.0Level: PTClassification code: 10072378Term: Encephalitis autoimmune Class: 100000004852; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2024-514494-21-00
• Lead Sponsor: Friedrich-Schiller-Universitaet Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Clinically diagnosed severe autoimmune encephalitis (defined as mRS = 3), Autoantibodies against neuronal surface proteins in cerebrospinal fluid or serum serum, detection must not be older than 4 weeks, calculated before randomization, Pre-treatment with rituximab, Age = 18 years, 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, Potentially fertile patient (up to 2 years after menopause): negative pregnancy test

Exclusion Criteria

Lactation, Acute infiltrative lung disease, Acute infiltrative pericardial disease, Malignant tumor under ongoing or newly started chemotherapy, Concurrent participation in another intervention study, Previous participation in this study, Known hypersensitivity to any ingredient of the investigational product, Continued therapy with glucocorticoids/rituximab during the duration of the study (last administration must be completed before first administration of investigational product)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified