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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07216391
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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. Each infusion takes about 30 minutes and is 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

Start date
Jul 30, 2026
Status verified
May 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. Each infusion takes about 30 minutes. Vital signs will be monitoring 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Jennifer Hosford
[email protected]
(352) 294-5759
Danielle Poulton
[email protected]
352-294-5761
Michael J Haller, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Florida· Gainesville, FL

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