6 results
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
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…
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
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.
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.