11 results
The main purpose of this study is to investigate the effect of nipocalimab on how quickly and to what extent etanercept or hydroxychloroquine is absorbed, distributed, metabolized and eliminated from the body. The study consists of 2 parts, Part 1…
Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular mortality and morbidity in subjects with T2DM and the clinical diagnosis of DKD.
Demonstrate whether, in addition to standard of care (SoC), finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of…
Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age, the safety and tolerability of treatment with nipocalimab in children and…
The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren*s syndrome (pSS) versus placebo.
Part A (Single Ascending Dose):Primary: To assess the safety and tolerability of single oral doses of PRAX-628 Secondary: To evaluate the pharmacokinetics (PK) of single oral doses of PRAX-628 Part B (Multiple Ascending Dose):Primary: To assess the…
In this study we will investigate how safe the new compound nipocalimab is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent nipocalimab is absorbed, transported, and eliminated…
Main objective:The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR than either empagliflozin or finerenone alone.Secondary objectives:- To further investigate the efficacy…
The main goal of this study is to find out whether finerenone in combination with either an ACE inhibitor or an ARB can reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a drug, but contains no…
A study to learn more about how safe the study treatment finerenone is inlong-term use when taken with an ACE inhibitor or angiotensin receptorblocker over 18 months of use in children and young adults from 1 to 18years of age with chronic kidney…