10 results
To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies.The primary efficacy endpoint of this study is * Overall survivalThe secondary efficacy endpoints of this…
The aim of the study is to evaluate the efficacy and safety of three IV treatment regimens of sifalimumab in adult subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE (Standard Of Care treatment for SLE).…
1. To investigate the safety and tolerability of single oral doses of NS11821 in healthy male subjects and estimate a maximum tolerated dose.2. To investigate the pharmacokinetics (PK) of single ascending oral doses of NS11821.
Primary objective:- To demonstrate the efficacy of twice-weekly s.c. 1080-mg infusions of pegcetacoplan compared with that of placebo in patients with CAD.Secondary objectives:- To demonstrate the effect of pegcetacoplan on the number of PRBC…
The objectives of the study are to assess safety and tolerability, pharmacokinetics (PK), and biological activity (including efficacy and pharmacodynamics [PD]) of multiple subcutaneous doses of pegcetacoplan in pediatric patients with paroxysmal…
The primary objective of this study is to assess the efficacy of twice per week subcutaneous (SC) doses of pegcetacoplan 1080 mg compared toplacebo in subjects with sporadic ALS as measured by the Combined Assessment of Function and Survival (CAFS)…
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with sJIA in order to identifythe dose and regimen for continued development in this population.
Primary:To evaluate the efficacy of pegcetacoplan in improving the underlying pathophysiology of complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) after 12 weeks of treatment.Secondary:• To evaluate…
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).
The primary objective of this study is to assess the efficacy of twice-weekly SC doses of pegcetacoplan compared with that of placebo in patients with primary C3G or IC-MPGN on the basis of a reduction in proteinuria in the setting of stable or…