7 results
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
This study investigates the safety and efficacy of the new drug anifrolumab in patients with Lupus Nephritis. The effect of anifrolumab is compared with the effect of a placebo. Anifrolumab and placebo ("the study drug") are added to the…
The primary, secondary and exploratory objectives of the study are as follows:Part APrimary:• To evaluate the safety and tolerability of the different GEH200520 Injection mass doses and a fixed dose of GEH200521 (18F) Injection when administered…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
The objective of this study is to evaluate the clinical efficacy, biological effects and safety of anifrolumab treatment in pSS.