Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Running, not enrolling · Phase 4

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT05757713

Run by

Sanofi

People needed

20

Starts

2023-07-25

Expected to finish

2026-08-27

Last updated by the study team

2026-01-30

Who can join

Age: any, up to 7. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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