Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes (KIBOU-T1D)
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
Listed as NCT06791291, this observational or N/A phase trial focuses on Type 1 Diabetes Mellitus and remains actively recruiting participants. Sponsored by Sanofi, it has been updated 12 times since 2025, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Total study duration is approximately 756 days.
Total study duration is approximately 756 days.
Status Flow
Change History
12 versions recorded-
Apr 13, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
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Jan 2026 — Present [monthly]
Recruiting PHASE2
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Jan 2026 — Present [monthly]
Recruiting PHASE2
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE2
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE2
▶ Show 7 earlier versions
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Sep 2025 — Nov 2025 [monthly]
Recruiting PHASE2
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE2
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE2
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Mar 2025 — May 2025 [monthly]
Not Yet Recruiting PHASE2
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Feb 2025 — Mar 2025 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility 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.
Contact Information
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Chūō, Japan , Fukuoka, Japan , Ichikawa, Japan , Iruma, Japan , Kobe, Japan , Kyoto, Japan , Osaka, Japan , Sapporo, Japan , Tokyo, Japan , Yahaba, Japan and 1 more location