CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
teplizumab 1 mg/mLdrug
Likely dose
teplizumab 1 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04270942
NCT04270942Phase 2Completed
CompareCT.gov

An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes

Provention Bio, a Sanofi Company·interventional·Posted Feb 17, 2020·Updated Feb 12, 2025

In Brief

A Phase 2 clinical trial evaluating teplizumab 1 mg/mL for Diabetes Mellitus, Type 1. Completed, enrolled 6 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartFeb 26, 2020
Primary CompletionJan 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.4 years ago

Interventions

teplizumab 1 mg/mLdrug

Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody). Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily