3 results
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
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…
Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…