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RECRUITING Phase 3

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

NCT05503264 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • OTHER Placebo
  • DRUG Satralizumab

Study Locations (20)

California

  • UC San Diego — La Jolla
  • Hoag Memorial Hospital — Newport Beach
  • UCSF- Multiple Sclerosis Centre — San Francisco

Maryland

  • University of Maryland Medical Center — Baltimore
  • Johns Hopkins Hospital — Baltimore

Ohio

  • University Hospitals of Cleveland — Cleveland
  • Cleveland Clinic Foundation — Cleveland

Alabama

  • University of Alabama at Birmingham — Birmingham

Colorado

  • University of Colorado — Aurora

District of Columbia

  • Childrens National Health Center — Washington D.C.

Georgia

  • Children's Healthcare of Atlanta Center for Advanced Pediatrics — Atlanta

Iowa

  • University of Iowa Hospitals & Clinics — Iowa City

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2022-09-27
Est. Completion 2029-12-14
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05503264

The ClinicalTrials.gov registry entry for NCT05503264 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with NMDAR Autoimmune Encephalitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05503264 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Maryland, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05503264 about?

NCT05503264 is a clinical study titled "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". The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.

What is the current status of trial NCT05503264?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2022-09-27. Estimated completion is 2029-12-14.

What conditions does trial NCT05503264 study?

This clinical trial studies the following conditions: NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05503264?

The interventions under investigation include: Placebo (OTHER), Satralizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05503264?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05503264 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial