5 results
The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…
Primary objective:The primary objective is to evaluate the efficacy of Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen, compared to placebo in terms of preserving endogenous insulin secretion as measured by C-…
* to describe the safety profile for qW, q2W and q3W regimens. * to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)* to describe the pharmacokinetics (PK) of single-agent RO6895882. Substudy BP28920/IMGThe study is designed to…
The primary outcome parameter is the Gout Activity Score (GAS)after 6 months of rasburicase treatment. Secondary outcome parameters are the serum uric acid concentration, the clinical evaluation of tophus load, patient reported outcomes: MD-HAQ, GAQ…
The primary objective is to assess the effect of three doses of Diamyd compared to a placebo in terms of (1) beta cell function; and (2) control of blood glucose levels in adolescents and adults recently diagnosed with type 1 diabetes (T1D) and who…