4 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary ObjectivesThe primary objectives of this study are:Phase I, Part A - Dose Escalation:• To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CB-103 as a single agent when administered orally and with repeat…
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in each of the following cohorts: • NMDAR autoimmune encephalitis (AIE) cohort: adults and adolescents (12-16) with definite…
The primary objective to demonstrate that in CNOpatients with pain 3-monthly treatment with pamidronate will result in significant decrease in maximum pain score (as measured with BPI) as compared to placebo.Secondary objectives:•…