NCT07360080

Long-Term Outcomes of Teplizumab in Routine Clinical Care

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Teplizumab	This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Timeline

• Start date: 2026-03-19
• Primary completion: 2035-10-29
• Completion: 2035-10-29
• First posted: 2026-01-22
• Last updated: 2026-04-17

Locations

2 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study