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Phase 2RecruitingNCT06791291

Teplizumab in Japanese stage-2 T1D

What this study tests

Sanofi phase 2 study testing the approved teplizumab delay regimen in Japanese participants aged 1–34 with stage-2 type 1 diabetes (KIBOU-T1D).

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-07-01.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Japanese participants aged 1–34 with stage-2 T1D (live registry). Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results posted. Recruiting; estimated n=10; actual start 25 July 2025; estimated primary completion 6 March 2028. Live registry ages are 1–34 years (was written as 8–34). Last update 1 July 2026.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: Japan. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Stage-3 T1D per ADA criteria through Week 104, per registry
  • Change from baseline in C-peptide AUC through Week 104, per registry
  • Safety and tolerability (TEAEs, SAEs, discontinuations, AESIs) through ~756 days, per registry

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]