5 results
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…
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…
This is a clinical performance study of PD-L1 IHC 22C3 pharmDx on non-squamous non-small cell lung cancer specimens. PD-L1 IHC 22C3 pharmDx will be used to select non-squamous NSCLC patients eligible for the TROPION-Lung07…
The purpose of this first-in-human study is to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses (MADs) of DYNE-101 administered intravenously (IV) to participants with DM1.…
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…