NCT03835728

Efficacy of Ocrelizumab in Autoimmune Encephalitis

Exploratory Study of Efficacy of Ocrelizumab in Autoimmune Encephalitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autoimmune Encephalitis

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months.
DRUG	Saline	This will be the matching placebo used in the study.

Timeline

• Start date: 2019-01-22
• Primary completion: 2020-10-02
• Completion: 2020-10-02
• First posted: 2019-02-11
• Last updated: 2021-10-19
• Results posted: 2021-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study