Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Study acronym: PETITE-T1D
StatusCompleted
PhasePhase 4
SponsorSanofi
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 23 participants (planned 20)
    • Primary and study completion dates changed from estimate of Aug 27, 2026 to Aug 28, 2026
    • Eligibility criteria expanded, about 6 words
    • Study description revised
    • Site details revised at 2 of 10 sites
    • Publications: details revised at 2 of 2 entries
  2. Lead sponsor: Provention Bio, a Sanofi Company to Sanofiv13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Oct 2026 to Aug 27, 2026
    • Study sites revised (10)
    v12
  4. Lead sponsor: Provention Bio, Inc. to Provention Bio, a Sanofi Companyv11
  5. Primary endpoints: 2 to 1
    • Secondary endpoints revised (3)
    • Study description shortened, about 12 words
    • Site contacts updated at 10 of 10 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 9 to 10v9
  2. Study sites: 8 to 9v8
  3. Study sites: 7 to 8v7
  4. Study sites: 5 to 7
    • Start date changed from estimate of May 2023 to Jul 25, 2023
    v6
  5. Study sites: 4 to 5v5
  6. Study sites: 1 to 4v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  8. Secondary endpoints: 2 to 3v2
  1. Study First Submitted
  • 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.
Sanofi
285 trials monitored
See 12 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Type 1 Diabetes
888 trials monitored
See 39 trials at risk
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.
Trial Details
NCT Number NCT05757713
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Diabetes Mellitus, Type 1
Related terms Diabetes Mellitus, Type 1
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov