5 results
Main objective: The main objective of this open-label, single arm study is to further characterize the safety, tolerability and effectiveness profile of olesoxime in SMAThe primary safety objective for this study is as follows:To evaluate the safety…
Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…