A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Public ClinicalTrials.gov record NCT05271409. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
Study identification
- NCT ID
- NCT05271409
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 139 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 30, 2022 (Actual)
- Primary completion
- Nov 20, 2025 (Actual)
- Completion
- May 20, 2028 (Estimated)
- Last update posted
- Oct 16, 2026
2022 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of California Irvine - Manchester Pavilion | Irvine | California | 92697 | — |
| University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) | Aurora | Colorado | 80045 | — |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| University of Florida College of Medicine Gainesville | Gainesville | Florida | 32608 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis | Owosso | Michigan | 48867 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55902 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| NYU Langone | New York | New York | 10003 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44915 | — |
| Premier Neurology | Greenville | South Carolina | 29605 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05271409, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05271409 live on ClinicalTrials.gov.