NCT07088068

A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes

A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 723 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

Detailed description

The study duration for one participant will be approximately 84 weeks (18 months).

Conditions

• Type 1 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2025-08-06
• Primary completion: 2028-06-06
• Completion: 2028-12-12
• First posted: 2025-07-28
• Last updated: 2026-04-14

Locations

137 sites across 16 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study