Teplizumab in pediatric stage-2 T1D
What this study tests
Phase 4/pediatric stage-2 teplizumab study (PETITE-T1D), relevant after the expanding Tzield label and screening-to-treatment pathway.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2026-09-29.
Most recent recorded citation date: 2026-09-29. 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?
- See registry for full inclusion/exclusion criteria. 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
- Completed 28 August 2026 with actual enrolment of 23 (registry updated 29 September 2026, checked 19 October 2026). No tabular results are posted on ClinicalTrials.gov yet; interim data from this single-arm study supported the April 2026 US FDA label expansion of Tzield to children aged 1 year and older.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 States. 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
- Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT05757713: Teplizumab in pediatric stage-2 T1D · Trial registry · 2026-09-29 — Completed 28 August 2026 (registry update posted 29 September 2026, checked 19 October 2026); actual enrolment n=23; no tabular results posted on ClinicalTrials.gov.