Teplizumab managed-access programmes: retrospective real-world cohort
What this study tests
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.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-26.
Most recent recorded citation date: 2026-08-26. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- People who received at least one day of teplizumab in a managed-access programme. Anyone in an interventional trial on the index date is excluded. 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. 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.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: United Kingdom, European Union. 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
- Demographics, family history, genetic risk and medical history at teplizumab initiation
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.
Sources
- [1]Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · Trial registry · 2026-08-26