NCT05757713

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 0 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.

Detailed description

This is a single-arm, non-randomized, open-label, multicenter study in the U.S. to assess the safety and pharmacokinetics of teplizumab in pediatric participants with Stage 2 type 1 diabetes (T1D) (two T1D-related autoantibodies and dysglycemia) who are 0 to \<8 years of age. Anti-drug antibodies/neutralizing antibodies (ADA/NAb) will also be assessed. Approximately 20 participants will be enrolled. The regimen consists of an intravenous infusion of teplizumab once daily for 14 consecutive days. The study duration for each individual may last up to approximately 26 months. The safety, tolerability, PK, ADA, and T1D clinical feature data will be summarized using descriptive statistics.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BIOLOGICAL	teplizumab	CD3-directed humanized monoclonal antibody

Timeline

• Start date: 2023-07-25
• Primary completion: 2026-08-27
• Completion: 2026-08-27
• First posted: 2023-03-07
• Last updated: 2026-01-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study