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Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

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Trial Profile

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Oct 2025

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At a glance

  • Drugs Teplizumab (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacokinetics; Registrational
  • Acronyms PROTECT
  • Sponsors MacroGenics; Provention Bio

Most Recent Events

  • 20 Oct 2025 According to Sanofi media release, US Food and Drug Administration (FDA) has accepted for expedited review the supplemental biologics license application (sBLA) for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes (T1D) in adults and pediatric patients eight years of age and older recently diagnosed with stage 3 T1D. The FDA nominated Tzield for the Commissioners National Priority Voucher (CNPV) pilot program based on its potential to address a large unmet medical ne
  • 25 Jun 2024 According to a Breakthrough Therapeutics media release, data from this study presented at the American Diabetes Association's (ADA) 84th Scientific Sessions.
  • 18 Oct 2023 Results assessing beta-cell preservation, clinical end points, and safety in children and adolescents who were assigned to receive teplizumab or placebo for two 12-day courses, published in the New England Journal of Medicine.

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