5 results
Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…
The primary objective of the main non-inferiority study is to determine the safety of TACmono starting nine months after kidney transplantation in immunologically low-risk patients in terms of BPAR-rate 15 months after transplantation compared to…
Primary Objective* To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. Secondary Objectives* To assess the…
Main objective:To assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis (LN)Secondary objective:To assess the safety and tolerability of Orelvo…
Primary Objective: To investigate the kinetics of the anti-viral effects of VCS, compared to standard of care with TAC, on SARS-CoV-2 over 56 days, in stable KTRs.Secondary Objective: To assess the safety and tolerability of VCS in stable KTRs…