Efficacy of Ocrelizumab in Autoimmune Encephalitis

• Status: Terminated
• Trial end date: 2020-10-02
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study is a randomized, double-blind, placebo controlled study of the efficacy of ocrelizumab in autoimmune encephalitis. Subjects with new diagnosis of autoimmune encephalitis will be invited to enroll in this study. Subjects will be randomized to receive ocrelizumab (an anti-CD20 therapy) or matched placebo, and will undergo three infusions over a six month period. Subjects will complete clinical visits over the study period, during which safety monitoring and neuropsychological assessments will be performed to assess for signs of clinical worsening from encephalitis. The primary outcome of this study is the proportion of patients who fail to complete the twelve month period without clinical worsening, as defined by the protocol. Subjects who experience early clinical worsening during the study may be offered open-label treatment with ocrelizumab at the discretion of the investigators.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Genentech, Inc.
• Treatments: Ocrelizumab

Criteria

Inclusion Criteria:

1. Age 18 or greater

2. Able to obtain informed consent from patient or appropriate designee

3. Possible autoimmune encephalitis as defined by Table 1:

1. Reasonable exclusion of alternative causes

2. Subacute onset (< 3 months) of memory deficits, altered consciousness, and/or psychiatric symptoms

3. One or more of the following:

• CSF (cerebrospinal fluid) pleocytosis (>5 cells/µl corrected, if necessary, for traumatic lumbar puncture)

• EEG (electroencephalogram) with epileptiform or focal slow wave abnormalities involving temporal lobes

• Brain abnormalities on T2/FLAIR MRI restricted to the mesial temporal (limbic) lobes

• Associated dyskinesias (faciobrachial dystonic movements or orofacial dyskinesias)

4. Completed initial treatment with iv steroids (at least 3000mg solumedrol) and plasma exchange (at least 3 exchanges) within the past 8 weeks

5. Presence of one (or more) of the following autoantibodies in serum or CSF

• NMDA receptor

• LGI1

• CASPR2

• DPPX

Exclusion Criteria:

1. Prior immunosuppression treatment in past year (other than steroids, intravenous immunoglobulin and plasma exchange)

2. Active malignancy requiring chemotherapy

3. Pregnancy

4. Evidence of active hepatitis or tuberculosis infection

5. Medical condition that (in investigators opinion) precludes the use of ocrelizumab