Teplizumab in Pediatric Stage 2 Type 1 Diabetes
PETITE-T1D
Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)
2 other identifiers
interventional
20
1 country
10
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2023
Typical duration for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 27, 2026
January 30, 2026
January 1, 2026
3.1 years
February 13, 2023
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)
Safety and tolerability endpoint
Through 104 Weeks
Secondary Outcomes (3)
Serum concentrations of teplizumab
Sparse PK samples between Days 1 and 28
Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab)
Through 104 weeks
CD3 receptor occupancy
Days 1 and 9
Study Arms (1)
teplizumab injection
EXPERIMENTALteplizumab injection, sterile solution for intravenous use
Interventions
Eligibility Criteria
You may qualify if:
- Participant is a male or female 0 to \< 8 years of age, inclusive, at Day 1
- Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)
You may not qualify if:
- Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
- Has an active infection and/or fever
- Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (10)
UCSF Medical Center Site Number : 107
San Francisco, California, 94143, United States
Barbara Davis Center for Diabetes Site Number : 102
Aurora, Colorado, 80045, United States
Yale University School of Medicine Site Number : 101
New Haven, Connecticut, 06511, United States
Centricity Research Site Number : 104
Columbus, Georgia, 31904, United States
Indianapolis University Health Riley Hospital for Children Site Number : 110
Indianapolis, Indiana, 46202, United States
UBMD Pediactrics Site Number : 105
Buffalo, New York, 14203, United States
Children's Hospital of Philadelphia Site Number : 108
Philadelphia, Pennsylvania, 19104, United States
Sanford Diabetes and Thyroid Clinic Site Number : 106
Sioux Falls, South Dakota, 57105, United States
Vanderbilt Univerity Medical Center Site Number : 109
Nashville, Tennessee, 37232, United States
MulitCare Institute for Research & Innovation Site Number : 103
Tacoma, Washington, 98405, United States
Related Publications (2)
Gitelman SE, Simmons K, Sherr JL, Leichter SB, Quattrin T, Russell WE, Sunil B, Willi SM, Knecht LA, Niemoeller E, Licaj I, Schmider W, Miller D, DiMeglio LA. Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes. Diabetologia. 2026 Feb;69(2):330-342. doi: 10.1007/s00125-025-06586-1. Epub 2025 Nov 6.
PMID: 41196293DERIVEDNovograd J, Frishman WH. Teplizumab Therapy to Delay the Onset of Type 1 Diabetes. Cardiol Rev. 2024 Nov-Dec 01;32(6):572-576. doi: 10.1097/CRD.0000000000000563. Epub 2023 May 9.
PMID: 37158990DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
March 7, 2023
Study Start
July 25, 2023
Primary Completion (Estimated)
August 27, 2026
Study Completion (Estimated)
August 27, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org