NCT06791291

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes

Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 8 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 8 Years – 34 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment. Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA. Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 8 to 34 years.

Detailed description

Total study duration is approximately 756 days.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Teplizumab	Pharmaceutical form:Solution for injection-Route of administration:Intravenous infusion

Timeline

• Start date: 2025-07-25
• Primary completion: 2028-03-06
• Completion: 2028-03-06
• First posted: 2025-01-24
• Last updated: 2026-04-13

Locations

11 sites across 1 country: Japan