drugset / Trial / NCT07216391
Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
Phase 2
Not yet recruiting
60 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.
Timeline
- Start
- 2026-07-30
- Primary completion
- 2029-11-30
- Completion
- 2030-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Comparator | Teplizumab | Monoclonal antibody | — | Intravenous |