Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods: Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
IMU-838 tablets
Placebo matching IMU-838 tablets
Efficacy of IMU-838 versus placebo
Annualized rate of percent brain volume change (PBVC) during MT period
Time frame: 120 weeks
Efficacy of IMU-838 versus placebo
Annualized rate of change in brain parenchymal fraction (BPF) during MT Period
Time frame: 120 weeks
Efficacy of IMU-838 versus placebo in terms of disability worsening
Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during MT Period
Time frame: 120 weeks
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