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

Conditions

• Type 1 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

4 Years - 34 Years

Healthy Volunteers

Not accepted

Interventions

• Antithymocyte Globulin (ATG) — DRUG
  Thymoglobulin
• Teplizumab — DRUG
  Intravenous infusions of teplizumab given for 14 consecutive days. For participants ages 8-34 each infusion will take a minimum of 30 minutes. For participants ages 4-7 each infusion will take a minimum of 2 hours. Each infusion will also be followed by an observation period of at least 30 minutes.

Study Details

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.

Key Dates

First listed

Oct 14, 2025

Start date

Jul 29, 2026

Status verified

Sep 2026

Primary completion

Nov 30, 2029

Completion

May 30, 2030

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: ATG
  Antithymocyte globulin (ATG) will be intravenously administered over two days, with a total of 2 infusion periods. The first dose (0.5mg/kg) will be infused over a minimum of 6 hours, and the second dose (2mg/kg) over a minimum of 4 hours with a maximum infusion time for each infusion of 10 hours. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.
• Active Comparator: Teplizumab
  Intravenous infusions of teplizumab will be given for 14 consecutive days. For participants between the ages of 8-34 each infusion will be given over a minimum of 30 minutes. For participants between the ages of 4-7 the infusion will be given over a minimum of 2 hours. Vital signs will be monitored for at least 30 minutes after each infusion. If reactions to the infusion occur participants may be monitored for at least 2 hours after the study drug infusion. The total dose for the 14-day course is approximately 11,240 µg/m².

Primary Outcome Measure

Change in DPTRS at six months [ Time Frame: 6 months after completion of study drug administration ]

Central Contacts

• Melissa Parker
  813-396-9378
  [email protected]

Locations (6)

Find similar trials in Aurora, CO

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