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NCT05503264 · ClinicalTrials.gov registry record · 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
A Phase 3 study of NMDAR Autoimmune Encephalitis and LGI1 Autoimmune Encephalitis, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT05503264: Recruiting Phase 3 study of NMDAR Autoimmune Encephalitis and LGI1 Autoimmune Encephalitis, sponsored by Hoffmann-La Roche.
NCT05503264 is a Phase 3 study of NMDAR Autoimmune Encephalitis and LGI1 Autoimmune Encephalitis that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05503264, a Phase 3 study of NMDAR Autoimmune Encephalitis and LGI1 Autoimmune Encephalitis, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2029-12-14 |
| Phase | Phase 3 |
What NCT05503264 shows while recruiting
NCT05503264 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
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.
NCT05503264 names 20 study sites across 16 states, led by California, Maryland, Ohio.
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.
What interventions are being tested in trial NCT05503264?
The interventions under investigation include: Placebo (OTHER), Satralizumab (DRUG).
Who is sponsoring clinical trial NCT05503264?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05503264's enrollment target sits among peer trials
152 1514th of 2000 higher than 484 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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