5 results
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
Main objective: Proportion of subjects who remain treatment-free.Secondary objectives: - Change from Baseline in Patient Reported Outcomes (PROs) (PROMISPF, EQ-5D-5L)- Safety: Total number of subjects in the safety analysis set with any AEcollected…
The main objective of Study M15-722 is to characterize the efficacy, safety, and tolerability of ravagalimab (ABBV-323) as induction treatment in subjects with moderately to severely active UC.
Primary ObjectivesTo assess the effects of pexidartinib on the PK parameters of single-dose midazolam and tolbutamide in patients.Secondary ObjectivesTo evaluate:- To determine the overall response rate (ORR) in patients with TGCT,kit-mutant…