Study to Evaluate the Efficacy and Safety of Satralizumab in FSHD1

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 24, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Facioscapulohumeral Muscular Dystrophy 1
Interventions
DRUG

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.

DRUG

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.

Trial Locations (2)

Unknown

CHEO Research Institute Ottawa, Ottawa

06000

CHU de Nice, Nice

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER