7 results
Primary: To characterize the QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment.Secondary (only key parameters): The percentage of patients…
Primary: To demonstrate the efficacy of QGE031 relative to placebo at 12 weeks in patients withatopic dermatitis (AD) as assessed by Eczema Area and Severity Index (EASI).Secondary: efficacy assessed by Investigator Global Assessment (IGA, 12 weeks…
In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…
To evaluate the efficacy, safety and tolerability of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to placebo on top of SoC in atopic patients with asthma.
PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…
The primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis (ie, proportion ofpatients achieving lactate dehydrogenase (LDH) * 1.5× upper limit of normal (ULN) over 26 weeks) of…
The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patientswith active PNH who are treatment-naive to complement inhibitor therapy or have not recently received…