Long-Term Outcomes of Teplizumab in Routine Clinical Care
Recruiting now
Conditions studied: Type 1 Diabetes
In brief
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Key facts
- Study ID
- NCT07360080
- Run by
- Sanofi
- People needed
- 1000
- Starts
- 2026-03-19
- Expected to finish
- 2035-10-29
- Last updated by the study team
- 2026-05-27
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Investigational Site Number: 8400003 — Atlanta, Georgia, United States (enrolling)
- Investigative Site Number: 8400004 — Atlanta, Georgia, United States (enrolling)
- Investigative Site Number: 8400002 — Syosset, New York, United States (enrolling)
- Investigational Site Number: 8400005 — Sandy City, Utah, United States (enrolling)
- Investigative Site Number: 3760003 — Petah Tikva, Israel (enrolling)
- Investigative Site Number: 3760002 — Ramat Gan, Israel (enrolling)
- Investigational Site Number: 3760001 — Ramat Gan, Israel (enrolling)
- Investigative Site Number: 7840001 — Abu Dhabi, United Arab Emirates (enrolling)
Full record on ClinicalTrials.gov
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