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.
Phase of Trial: Phase II/III
Latest Information Update: 09 Jun 2016
At a glance
- Drugs Teplizumab (Primary)
- Indications Type 1 diabetes mellitus
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PROTEGE
- Sponsors MacroGenics
- 31 Aug 2018 Biomarkers information updated
- 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).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History