Teplizumab in New-Onset Type 1 Diabetes

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This is a study that investigates whether an IV medication (teplizumab) will slow or halt the progression of type 1 diabetes in children and adolescents (ages 8 - 17 years). Eligible participants will be randomly assigned to receive either the study medication or an inactive substance called a placebo. All participants will receive two courses of IV infusions, six months apart from each other. During each treatment course, participants will come to CHOP for daily teplizumab or placebo infusions for 12 days. Study participation, including treatments and follow-up visits, lasts for 1.5 years.

Eligibility & Criteria

IRB #:
19-016332
Official Title:
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)
Study Phase:
Phase III
Eligible Age Range:
8 - 17 Years
Gender:
All
Study Categories:
Leader
Steven M. Willi, MD

Steven M. Willi, MD