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TN-10 trial design1,2

T1D Illustration
Design
  • Randomized, double-blind, placebo-controlled study1

Objective
  • Demonstrate whether teplizumab can delay or prevent T1D in at-risk patients1

Population
  • ≥8 years of age, relative of a patient with T1D1
  • Abnormal glucose tolerance (dysglycemia)1
  • ≥2 T1D-related autoantibodies1

Treatment
  • One 14-day course of teplizumab by intravenous infusion1
Primary endpoint
  • Time from randomization to development of T1D1
  • Defined as first of two consecutive diagnostic oral glucose tolerance tests (OGTTs) (measured 3 and 6 months after treatment and every 6 months after)1


Study duration: ~7 years2
Enrollment (total N=76): 6 years (2011-2017)2
Time from last patients enrolled to time to reach primary endpoint: 1 year (2017-2018)2

Once enrolled, primary endpoint analysis was initiated when 40 participants were diagnosed with clinical T1D.1

  • Median follow-up ~2 years: 75% >3 years1
  • Approximately 70% <18 years of age1

1. Herold KC, Bundy BN, Long SA, et al; for Type 1 Diabetes TrialNet Study Group. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603-613. 2. Data on file. Provention Bio, Inc. 2020.