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A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

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A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Dec 2023

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At a glance

  • Drugs Teplizumab (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PROTEGE
  • Sponsors MacroGenics

    • Most Recent Events

    • 30 Nov 2023 Study design changed from parallel to sequential. Number of treatment arms increased from 4 to 5, 2 more primary end points added.
    • 05 Oct 2012 Two-year results assessing C-peptide levels presented at the 48th Annual Meeting of the European Association for the Study of Diabetes.
    • 23 Sep 2011 Actual end date Aug 2011 added as reported by ClinicalTrials.gov parent record (NCT00385697).

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