8 results
Primary ObjectivesThe primary objectives of the study are:· To determine the efficacy of Epanova 2 g daily compared to olive oil 2 g daily for 12 weeks in lowering serum TG levels in subjects with severehypertriglyceridemia (TG levels *500 mg/dL [5.…
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
The purpose of this study is to allow collection of safety and tolerability data in subjects benefitting from treatment with spartalizumab as a single agent or in combination with other study treatments in a pre-defined (Appendix Section 16.1)…
The objective of the trial is to assess the efficacy and safety of nintedanib in the treatment ofSSc with ILD at a dose of 150 mg bid compared to placebo.
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. Additional efficacy and safety endpoints will be collected to explore potential long-term effects.Please see…
The main objective of the trial is to assess the safety and tolerability of long-term treatment with nintedanib in pediatric patients with clinically significant fibrosing ILD.See section 2.1 and 2.2 of the protocol.
Primary: To characterize the safety and tolerability of LXH254 single agent and to identify recommended doses for future studies in adult patients with advanced solid tumors harboring MAPK pathway alterations.To characterize the safety and…