A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type1 Diabetes (T1D)
Study ID: STU-2019-1046
it is a 2 to 3 infusing study using teplizumab. The patients are newly diagnosed with type 1 diabetes and come in for their screening appointment. if all goes well, they get randomized and will do 12 daily infusions consecutively then come back in for some followup appointments. Then they come back for another round of 12 daily infusions. The study last about 2 years.
The Primary objective of this study is: * To determine whether two courses of teplizumab administered 6 months apart slow the loss of [MiCRo-SYMBoL] cells and preserve [MiCRo-SYMBoL] cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks. The Secondary objectives of this study are: * To evaluate participant improvements in key clinical parameters of diabetes management, including insulin use, hemoglobin a1c (Hba1c), and clinically important hypoglycemic episodes * To determine the safety and tolerability of two courses of teplizumab, administered intravenously (iV) 6 months apart * To evaluate the pharmacokinetics (PK) and immunogenicity of two courses of iV teplizumab The exploratory objectives of this study are: * To assess [MiCRo-SYMBoL] cell function and T1D-focused clinical parameters * To evaluate immunologic, endocrinologic, molecular, and genetic markers