drugset / Trial / NCT04270942

At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

NCT04270942

Phase 2 Completed 6 enrolled Provention Bio, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

Timeline

Start
2020-02-26
Primary completion
2024-01-22
Completion
2024-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Teplizumab Monoclonal antibody 850 ug/m2 Intravenous