The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
In Part 1, study drug will be administered after all other study-related procedures have been performed at a site visit at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter. Participants will receive satralizumab according to body weight. Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. In Part 2, participants will be asked to choose from one of the following options: Option 1: continue on randomized, double-blind study drug; Option 2: start open-label satralizumab based on body weight; Option 3: stop study treatment and continue follow-up assessments.
Satralizumab placebo prefilled syringe (PFS) is identical in composition to satralizumab PFS, but does not contain the satralizumab active ingredient and will be identical in appearance and packaging to satralizumab. A PFS (assembled with an needle safety device \[NSD\] and extended finger flange) filled with 0.5 milliliters (mL) of solution, corresponding to 60 milligrams (mg) satralizumab, may be used in Part 2 once it becomes available at the study site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUC San Diego
La Jolla, California, United States
RECRUITINGHoag Memorial Hospital
Newport Beach, California, United States
RECRUITINGUCSF- Multiple Sclerosis Centre
San Francisco, California, United States
Part 1: Proportion of Participants in NMDAR AIE Cohort With Modified Rankin Scale (mRS) Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 24
Time frame: Baseline up to Week 24
Part 1: Proportion of Participants in LGI1 AIE Cohort With mRS Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 52
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants With Adverse Events (AEs)
Time frame: From Week 52 up to 2 years
Part 1 (NMDAR AIE Cohort and LGI1 Cohort): Time to mRS Score Improvement ≥ 1 From Baseline Without Use of Rescue Therapy
Time frame: Baseline up to Week 52
Part 1 (NMDAR AIE Cohort and LGI1 AIE Cohort): Time to Rescue Therapy
Time frame: Baseline up to Week 52
Part 1 (NMDAR AIE Cohort and LGI1 AIE Cohort): Proportion of Participants With Sustained Seizure Cessation at Week 24
Sustained seizure cessation is defined as 4 consecutive weeks of no seizures maintained until Week 24 and no use of rescue therapy.
Time frame: Baseline up to Week 24
Part 1 (NMDAR AIE Cohort): Change in Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score From Baseline at Week 24
Time frame: Baseline up to Week 24
Part 1 (LGI1 AIE Cohort): Change in CASE Score From Baseline at Week 52
Time frame: Baseline up to Week 52
Part 1 (NMDAR AIE Cohort): Montreal Overall Cognitive Assessment (MOCA) Total Score at Week 24
Time frame: Baseline up to Week 24
Part 1 (LGI1 AIE Cohort): MOCA Total Score at Week 52
Time frame: Baseline up to Week 52
Part 1 (LGI1 AIE Cohort): Rey Auditory Verbal Learning Test (RAVLT) Score at Week 52
Time frame: Baseline up to Week 52
Part 1 (NMDAR AIE Cohort): mRS Score at Week 24 (as Measured on a 7-point Scale)
Time frame: Baseline up to Week 24
Part 1: Percentage of Participants With AEs
Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5.0)
Time frame: Baseline, Week 52, 2 Years
Parts 1 and 2: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Time frame: Baseline up to 2 years
Reference Study ID Number: WN43174, https://forpatients.roche.com/
CONTACT
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University of Colorado
Aurora, Colorado, United States
RECRUITINGChildrens National Health Center
Washington D.C., District of Columbia, United States
RECRUITINGChildren's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia, United States
RECRUITINGUniversity of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
RECRUITINGUniversity of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITING...and 82 more locations