7 results
- To evaluate the safety and efficacy of anti-IgE therapy with respect to:Clinical disease activity (DAS44), laboratory parameters and adverse events. - To evaluate whether disease activity correlates with immunological parameters, including…
Aim of the study is to investigate what the influence is of insomnia on driving performance and to what extent this influence is attenuated by the use of hypnotics. Therefore, over-the-road driving performance of treated and untreated patients…
To relate the reduction of inflammatory characteristics in skin and in peripheral blood to clinical efficacy in patients with CSU. Major focusses of this study are the (early) effects on basophils and other Fc*RI-bearing leukocytes before, during,…
The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…
The primary objective of this study will be to determine the pharmacokinetic profile of lorazepam oral liquid 1 mg/ml in the paediatric ICU population, with specific attention for the population aged up to 12 years of age.The secondary objectives…
Primary Objectives:- Phase II: To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)- Phase III: To demonstrate the efficacy of IFX-1 to improve of symptoms and outcome of severe COVID-19 pneumonia (confirmative…
The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.Secondary objectives:*To assess safety and tolerability of IFX-1*To compare GC-induced toxicity of…