5 results
The purpose of this study is to investigate the safety and efficacy of rFVIIIFc in previously untreated patients (PUPs) in accordance with the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) guideline on the…
To demonstrate non-inferiority of a T2T strategy in which conventional synthetic disease modifying drugs (csDMARDs) refractory RApatients are initially treated with tsDMARD baricitinib versus the comparable T2T strategy in which patients are…
This study will assess the safety and tolerability of sotatercept in pediatric participants with PAH WHO Group 1 who receive PAH background therapy. In the absence of treatment, the majority of patients succumb to heart failure within a few years of…
The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung…
Primary:The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH.Secondary:The secondary objective is to follow…