Teplizumab in Pediatric Stage 2 Type 1 Diabetes

NCT05757713 · tracked via the Priya Life Science USA tracker

Sponsor

Sanofi

Phase

Phase 4

Started

2023-07-25

Last updated

2026-01-30

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

teplizumab →

teplizumab: CD3-directed humanized monoclonal antibody

Study 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.

Eligibility

Sex

ALL

Min age

0 Years

Max age

7 Years

Healthy volunteers

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.

Primary outcome measure(s)

Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs) — Through 104 Weeks
Safety and tolerability endpoint

Trial sites (10)

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

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Other trials for the same condition

Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes Recruiting

Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature Recruiting

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults Recruiting

A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity Recruiting

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05757713 on ClinicalTrials.gov ↗ ← All trials in the USA