Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)

January 28, 2026 updated by: Sanofi

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-arm, non-randomized, open-label, multicenter study in the U.S. to assess the safety and pharmacokinetics of teplizumab in pediatric participants with Stage 2 type 1 diabetes (T1D) (two T1D-related autoantibodies and dysglycemia) who are 0 to <8 years of age. Anti-drug antibodies/neutralizing antibodies (ADA/NAb) will also be assessed.

Approximately 20 participants will be enrolled. The regimen consists of an intravenous infusion of teplizumab once daily for 14 consecutive days. The study duration for each individual may last up to approximately 26 months.

The safety, tolerability, PK, ADA, and T1D clinical feature data will be summarized using descriptive statistics.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Medical Center Site Number : 107
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center for Diabetes Site Number : 102
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University School of Medicine Site Number : 101
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Centricity Research Site Number : 104
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indianapolis University Health Riley Hospital for Children Site Number : 110
    • New York
      • Buffalo, New York, United States, 14203
        • UBMD Pediactrics Site Number : 105
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia Site Number : 108
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Diabetes and Thyroid Clinic Site Number : 106
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univerity Medical Center Site Number : 109
    • Washington
      • Tacoma, Washington, United States, 98405
        • MulitCare Institute for Research & Innovation Site Number : 103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 7 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant is a male or female 0 to < 8 years of age, inclusive, at Day 1
  2. Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)

Exclusion Criteria:

  1. Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
  2. Has an active infection and/or fever
  3. 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).
  4. Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: teplizumab injection
teplizumab injection, sterile solution for intravenous use
Biological: teplizumab
CD3-directed humanized monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)
Time Frame: Through 104 Weeks
Safety and tolerability endpoint
Through 104 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentrations of teplizumab
Time Frame: Sparse PK samples between Days 1 and 28
Pharmacokinetic (PK) endpoint
Sparse PK samples between Days 1 and 28
Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab)
Time Frame: Through 104 weeks
Immunogenicity endpoint
Through 104 weeks
CD3 receptor occupancy
Time Frame: Days 1 and 9
To assess the effects of teplizumab on cluster of differentiation 3 (CD3) receptor occupancy
Days 1 and 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

August 27, 2026

Study Completion (Estimated)

August 27, 2026

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRV-031-005
  • SFY18116 (Other Identifier: Sanofi Identifier)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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