Teplizumab managed-access programmes: retrospective real-world cohort
Recruiting Sanofi chart-review study of people who already received teplizumab for stage 2 T1D through managed-access programmes. It describes who was treated and how they were monitored; it does not assign a new drug. Distinct from the prospective AL1GN cohort.
Primary endpoints
- Demographics, family history, genetic risk and medical history at teplizumab initiation
Results so far
No results. Recruiting; estimated n=60 across about 15 sites in at least five countries (Belgium, France, Germany, Italy, Spain, UK). Actual start 16 March 2026; estimated primary completion 30 November 2026. Last registry update 26 August 2026.
The full picture
This is a retrospective chart review of teplizumab already given under managed access, not a new efficacy trial and not the same study as AL1GN (NCT07360080), which follows people prospectively for up to 10 years.