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Active, not recruiting Phase 4 Interventional

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

ClinicalTrials.gov ID: NCT05757713

Public ClinicalTrials.gov record NCT05757713. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05757713
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sanofi
Industry
Enrollment
20 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
0 Years to 7 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 24, 2023
Primary completion
Aug 26, 2026
Completion
Aug 26, 2026
Last update posted
Jan 29, 2026

2023 – 2026

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
UCSF Medical Center Site Number : 107 San Francisco California 94143
Barbara Davis Center for Diabetes Site Number : 102 Aurora Colorado 80045
Yale University School of Medicine Site Number : 101 New Haven Connecticut 06511
Centricity Research Site Number : 104 Columbus Georgia 31904
Indianapolis University Health Riley Hospital for Children Site Number : 110 Indianapolis Indiana 46202
UBMD Pediactrics Site Number : 105 Buffalo New York 14203
Children's Hospital of Philadelphia Site Number : 108 Philadelphia Pennsylvania 19104
Sanford Diabetes and Thyroid Clinic Site Number : 106 Sioux Falls South Dakota 57105
Vanderbilt Univerity Medical Center Site Number : 109 Nashville Tennessee 37232
MulitCare Institute for Research & Innovation Site Number : 103 Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05757713, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 29, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05757713 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →