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NCT05271409 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
A Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT05271409 is a Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) 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
NCT05271409, a Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), 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 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Satralizumab
Study Locations (20)
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinic Foundation - Cleveland
- OhioHealth Research Institute - Columbus
Florida
- University of Florida College of Medicine Gainesville - Gainesville
- Nemours Children's Clinic - of the Nemours Foundation - Jacksonville
Illinois
- Northwestern University - Chicago
- Consultants in Neurology Ltd - Northbrook
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic- Scottsdale - Scottsdale
California
- University of California Irvine - Manchester Pavilion - Irvine
Colorado
- University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) - Aurora
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2022-08-30 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05271409
The ClinicalTrials.gov registry entry for NCT05271409 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 1 condition, with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05271409 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Ohio, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05271409 about?
NCT05271409 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease". 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...
What is the current status of trial NCT05271409?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2022-08-30. Estimated completion is 2028-12-31.
What conditions does trial NCT05271409 study?
This clinical trial studies the following conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD).
What interventions are being tested in trial NCT05271409?
The interventions under investigation include: Placebo (OTHER), Satralizumab (DRUG).
Who is sponsoring clinical trial NCT05271409?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05271409 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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