Condition: Type 1 Diabetes Mellitus · Sponsor: Sanofi
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 1 to 34 years.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
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| Investigational Site Number : 3920015 | Ichikawa, Chiba, Japan | Recruiting |
| Investigational Site Number : 3920006 | Sapporo, Hokkaido, Japan | Recruiting |
| Investigational Site Number : 3920018 | Kobe, Hyōgo, Japan | Recruiting |
| Investigational Site Number : 3920007 | Yahaba, Iwate, Japan | Recruiting |
| Investigational Site Number : 3920019 | Yokohama, Kanagawa, Japan | Recruiting |
| Investigational Site Number : 3920001 | Iruma, Saitama, Japan | Recruiting |
| Investigational Site Number : 3920010 | Chūō, Yamanashi, Japan | Recruiting |
| Investigational Site Number : 3920017 | Fukuoka, Japan | Recruiting |
| Investigational Site Number : 3920016 | Kyoto, Japan | Recruiting |
| Investigational Site Number : 3920004 | Osaka, Japan | Recruiting |
| Investigational Site Number : 3920020 | Tokyo, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06791291