Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes.

ABSTRACT:

Aims/hypothesis

Teplizumab is approved in the USA and seven other countries to delay stage 3 type 1 diabetes onset in individuals ≥8 years of age with stage 2 type 1 diabetes. As part of a US Food and Drug Administration post-marketing requirement, this study evaluated the safety, tolerability and pharmacokinetics of teplizumab in children aged <8 years with stage 2 type 1 diabetes.

Methods

The PETITE-T1D trial is a 2 year single-arm, open-label, multicentre study of 23 children <8 years of age with stage 2 type 1 diabetes. Participants received a 14 day teplizumab course. A prespecified interim analysis was performed after 15 participants completed 1 year of follow-up and included all 23 participants. Primary endpoints included treatment-emergent adverse events (TEAEs), TEA

SUBMITTER: Gitelman SE 

PROVIDER: S-EPMC12779737 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature