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

Study acronym: TN40A
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Trial sites expanded: 1 → 6 locations · Start date changed from estimate of Jul 30, 2026 to Jul 29, 2026 · Eligibility criteria shortened, about 36 wordsv4 Show 3 more changesShow less
    • Trial sites expanded: 1 → 6 locations
    • Start date changed from estimate of Jul 30, 2026 to Jul 29, 2026
    • Eligibility criteria shortened, about 36 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Apr 15, 2026 to Jul 30, 2026 Secondary endpoints: 6 to 7 · Study description expanded, about 181 words · Eligibility criteria expanded, about 2 wordsv3 Show 3 more changesShow less
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 181 words
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Dec 1, 2025 to Apr 15, 2026 Primary completion date: Dec 31, 2029 to Nov 30, 2029 · Completion date: Dec 31, 2029 to May 30, 2030 · Eligibility criteria expanded, about 46 words · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2029 to Nov 30, 2029
    • Completion date: Dec 31, 2029 to May 30, 2030
    • Eligibility criteria expanded, about 46 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07216391
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes Mellitus
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov