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 Type 1 Diabetes (T1D)
This study enrolls children with type 1 diabetes. The study medication is called tepluzimab and has been administered to over 450 children with new onset T1D in prior trials and has shown promising improvement of beta cell function. The purpose of this study is to find out a definitive answer regarding the ability of teplizumab to help children with newly diagnosed type 1 diabetes in preserving their own insulin production.
Your child will be in this study for 18 months. 2/3 of the study participants will receive the study medication (teplizumab) and 1/3 will receive a placebo (which looks like the study medication but contains no active ingredient). Teplizumab/placebo will be given by an intravenous (IV) infusion into a vein by a nurse who is an expert in IV in children. The IV infusion takes about 30 minutes and is given daily for 12 days on two separate occasions, 6 months apart. The first infusion MUST start within 6 weeks from diagnosis of T1D. The study takes place at UBMD Pediatrics at the Conventus building in Buffalo, NY.
Compensation and reimbursement for travel expenses (included parking) are available.
To determine whether two courses of teplizumab administered 6 months apart slow the loss of beta cells and preserve beta cells and preserve beta 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.
Children ages 8-17 years (up to when a child turns 18) old who have been diagnosed with Type 1 diabetes in the last 6 weeks.
Let us know how the study team can reach you.
If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email email@example.com and someone will assist you.