46
Participants
Start Date
January 24, 2024
Primary Completion Date
March 31, 2027
Study Completion Date
March 31, 2027
Satralizumab Prefilled Syringe
Satralizumab is supplied as prefilled syringe with 1 millimeter of solution for subcutaneous injection corresponding to 120mg of satralizumab. During the first period (double blind period), satralizumab will be administered at weeks 0, 2, 4 and every 4 weeks until week 48. During the second period (open label period), satralizumab will be administered at weeks 48, 50, 52 and every 4 weeks until week 96.
Placebo Comparator
Placebo prefilled syringe is identical in composition to satralizumab, but does not contain the satralizumab active agent. It is identical in appearance and packaging to satralizumab. During the first period (double blind period), placebo will be administered at weeks 0, 2, 4 and every 4 weeks until week 48. During the second period (open label period), satralizumab will be administered at weeks 48, 50, 52 and every 4 weeks until week 96.
CHEO Research Institute Ottawa, Ottawa
CHU de Nice, Nice
Centre Hospitalier Universitaire de Nice
OTHER