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Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Study acronym: PETITE-T1D
StatusActive, Not Recruiting
PhasePhase 4
SponsorSanofi
Started2023-07-25
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 30, 2026 (before its estimated August 27, 2026 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 12 times since 2023-02-23; most recent filed 2026-01-28. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-01-28
Amendment Study Status, Sponsor/Collaborators v12
2024-09-12
Amendment Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations v11
2024-04-12
Amendment Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v10
2024-03-27
Amendment Study Status, Study Description, Conditions, Outcome Measures, Contacts/Locations v9
2023-12-11
Amendment Study Status, Contacts/Locations v8
2023-11-03
Amendment Study Status, Contacts/Locations v7
2023-10-23
Amendment Study Status, Contacts/Locations v6
2023-08-15
Amendment Study Status, Contacts/Locations v5
2023-05-22
Amendment Study Status, Contacts/Locations v4
2023-05-22
Amendment Study Status, Contacts/Locations v3
2023-05-01
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
2023-03-06
Amendment Study Status, Outcome Measures v1
2023-02-23
Original filing
Trial Details
NCT Number NCT05757713
Lead Sponsor Sanofi
Conditions Diabetes Mellitus, Type 1
Enrollment 20 participants
Start Date 2023-07-25
Primary Completion 2026-08-27 (estimated)
Study Completion 2026-08-27 (estimated)
Updated on ClinicalTrials.gov 2026-01-30