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NOT YET RECRUITING
NCT07216391
PHASE2

Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

View on ClinicalTrials.gov

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 be followed for 12 months after administration.

Official title: Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A

Key Details

Gender

All

Age Range

4 Years - 34 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-15

Completion Date

2030-05-30

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Antithymocyte Globulin (ATG)

Thymoglobulin

DRUG

Teplizumab

Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by an observation period of at least 30 minutes.

Locations (1)

University of Florida

Gainesville, Florida, United States