Clinical Trial

Long-Term Outcomes of Teplizumab in Routine Clinical Care

Study acronym: AL1GN
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 2 -> 8 locations 2026-05-28
critical Recruitment opened 2026-03-31
Trial Details
NCT Number NCT07360080
Lead Sponsor Sanofi
Conditions Type 1 Diabetes
Enrollment 1,000 participants
Start Date 2026-03-19
Primary Completion 2035-10-29 (estimated)
Study Completion 2035-10-29 (estimated)
Updated on ClinicalTrials.gov 2026-05-27