RecruitingPhase 2NCT06791291

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.


Sponsor

Sanofi

Enrollment

10 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 34 Years

Plain Language Summary

Simplified for easier understanding

This study is testing teplizumab — an immune-modifying drug already approved in the US to delay the development of type 1 diabetes — specifically in Japanese patients. Type 1 diabetes happens when the immune system attacks the insulin-producing cells in the pancreas. This trial is for people who are at high risk of developing type 1 diabetes but do not have it yet (Stage 2 — meaning abnormal blood sugar with multiple autoantibodies present). **You may be eligible if...** - You are between 8 and 34 years old (inclusive) - You were born in Japan or are of Japanese descent with all four grandparents born in Japan - You have tested positive for at least 2 type 1 diabetes-related autoantibodies (proteins that suggest the immune system is attacking the pancreas) - You have abnormal results on a blood sugar test confirming Stage 2 type 1 diabetes (pre-symptomatic) **You may NOT be eligible if...** - You already have clinical (symptomatic) type 1 diabetes (Stage 3) - You are not of Japanese descent as defined by the study criteria - You are under 8 or over 34 years old - You do not have at least 2 relevant autoantibodies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeplizumab

Pharmaceutical form:Solution for injection-Route of administration:Intravenous infusion


Locations(11)

Investigational Site Number : 3920015

Ichikawa, Chiba, Japan

Investigational Site Number : 3920006

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920018

Kobe, Hyōgo, Japan

Investigational Site Number : 3920007

Yahaba, Iwate, Japan

Investigational Site Number : 3920019

Yokohama, Kanagawa, Japan

Investigational Site Number : 3920001

Iruma, Saitama, Japan

Investigational Site Number : 3920010

Chūō, Yamanashi, Japan

Investigational Site Number : 3920017

Fukuoka, Japan

Investigational Site Number : 3920016

Kyoto, Japan

Investigational Site Number : 3920004

Osaka, Japan

Investigational Site Number : 3920020

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06791291


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