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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 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. The trial reports 20 study locations across 16 states.
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.