116
Participants
Start Date
March 30, 2022
Primary Completion Date
September 30, 2028
Study Completion Date
September 30, 2028
Inebilizumab
"RCP: Blinded treatment on Day 1, Day 15,~* Inebilizumab group: Inebilizumab 300 mg intravenous (IV)~* Placebo group: IV matching placebo Prior to enrollment, all participants will receive standard of care, including high-dose corticosteroids (minimum of 3 days of treatment, 1 g methylprednisolone daily or equivalent) AND either IVIg (total dose range between 1.2 and 2 g/kg) OR plasmapheresis (defined as 5 or 6 exchanges).~Rescue therapy will be given to participants in either treatment group based on the results of the Week 6 assessments. Rescue therapy is cyclophosphamide 750 mg/m2 IV followed by additional doses every 28-30 days until the mRS score is ≤ 3 (at site Principal Investigator's discretion under standard of care)."
Placebo
The placebo group will receive IV matching placebo on Day 1 and Day 15,
RECRUITING
Mount Sinai, New York
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Columbia University Medical Center, New York
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SUNY Downstate, Brooklyn
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SUNY Buffalo, Williamsville
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University of Rochester, Rochester
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University of Pittsburgh, Pittsburgh
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University of Pennsylvania, Philadelphia
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University of Virginia, Charlottesville
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Wake Forest University Health Sciences, Winston-Salem
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Emory University, Atlanta
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Mayo Clinic Jacksonville, Jacksonville
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University of Miami, Miami
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University of Alabama at Birmingham, Birmingham
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Vanderbilt University, Nashville
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Ohio State University, Columbus
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University of Cincinnati, Cincinnati
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University of Michigan Health System, Ann Arbor
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University of Iowa, Iowa City
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Mayo Clinic Rochester, Rochester
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Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago
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Northwestern University Feinberg School of Medicine, Chicago
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Washington University in St. Louis School of Medicine, St Louis
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University of Texas Southwestern Medical Center, Dallas
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Texas Children's Hospital, Houston
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Children's Hospital Colorado Main Campus, Aurora
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University of Colorado, Aurora
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University of Utah, Salt Lake City
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St. Joseph Hospital and Medical Center Barrow Neurological Institute, Phoenix
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Mayo Clinic in Arizona, Scottsdale
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Children's Hospital of Orange County, Orange
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UC Irvine, Orange
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UC Davis, Sacramento
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University of Washington, Seattle
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Yale University, New Haven
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Massachusetts General Hospital, Boston
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Erasmus Medical University Center, Rotterdam
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Erasmus University Rotterdam, Rotterdam
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Hospital Clínic Barcelona, Barcelona
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Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona
University of Utah
OTHER