NCT04270942

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Provention Bio, a Sanofi Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks. The purpose of this study was to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (IV) to participants in the NIH-sponsored trial who have developed type 1 diabetes and were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	teplizumab 1 mg/mL	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

Timeline

• Start date: 2020-02-26
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2020-02-17
• Last updated: 2025-02-12
• Results posted: 2025-02-12

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study