A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis

Conditions

• LGI1 Autoimmune Encephalitis
• NMDAR Autoimmune Encephalitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Satralizumab — DRUG
  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, administered as 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. As of Protocol Version 6, participants in the NMDAR cohort who chose Option 1 will transition to either Option 2 or Option 3 at the time of the primary analysis.
• Placebo — OTHER
  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.

Study Details

The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.

Key Dates

Start date

Sep 27, 2022

Status verified

May 2026

Primary completion

Dec 16, 2026

Completion

Dec 14, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NMDAR Autoimmune Encephalitis (AIE) Cohort
  Adults and adolescents with definite or probable NMDAR encephalitis will receive satralizumab as per the schedule specified in the protocol. As of Protocol Version 6, participants in Part 1 will transition to Part 2 at the time of primary analysis or at Week 52, whichever occurs first.
• Experimental: LGI1 AIE Cohort
  Adults with LGI1 encephalitis as per the schedule specified in the protocol.
• Placebo Comparator: NMDAR AIE Placebo Cohort
  Adults and adolescents with definite or probable NMDAR encephalitis will receive satralizumab placebo as per the schedule specified in the protocol. As of Protocol Version 6, participants in Part 1 will transition to Part 2 at the time of primary analysis or at Week 52, whichever occurs first.
• Placebo Comparator: LGI1 AIE Placebo Cohort
  Adults with LGI1 encephalitis will receive satralizumab placebo as per the schedule specified in the protocol.

Primary Outcome Measure

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 ]

Central Contacts

• Reference Study ID Number: WN43174, https://forpatients.roche.com/
  888-662-6728 (U.S.)
  [email protected]
• Global Medical Information:
  [email protected]

Locations (20)

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