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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2019

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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 Aug 2019 According to the Provention Bio media release, Dr. Sherron Kell will lead the PRV-031 (teplizumab) program, including the oversight of this study and clinical support of anticipated regulatory submissions.
    • 09 Apr 2019 According to the Provention Bio media release, If successful, this trial could serve as the basis for a Biologics License Application (BLA).
    • 09 Apr 2019 According to the Provention Bio media release, company expects to complete enrollent by the end of 2020.
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