Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Summary

The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.

Timeline

Start

2023-07-25

Primary completion

2026-08-27

Completion

2026-08-27

Publications

• Gitelman SE, Simmons K, Sherr JL, Leichter SB, Quattrin T, Russell WE, Sunil B, Willi SM, Knecht LA, Niemoeller E, Licaj I, Schmider W, Miller D, DiMeglio LA. Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes. Diabetologia. 2026 Feb;69(2):330-342. doi: 10.1007/s00125-025-06586-1. Epub 2025 Nov 6.
• Novograd J, Frishman WH. Teplizumab Therapy to Delay the Onset of Type 1 Diabetes. Cardiol Rev. 2024 Nov-Dec 01;32(6):572-576. doi: 10.1097/CRD.0000000000000563. Epub 2023 May 9.

Drugs

Indications