This study is in progress, not accepting new patients

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

a study on Diabetes Diabetes Type 1

Summary

Eligibility
for people ages 0-7 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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)

Details

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.

Keywords

Diabetes Mellitus, Type 1, Type 1 diabetes, Stage 2, Pediatric type 1 diabetes, T1D, At-risk, Diabetes Mellitus, Type 1 Diabetes Mellitus, teplizumab, teplizumab injection

Eligibility

You can join if…

Open to people ages 0-7

  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)

You CAN'T join if...

  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.

Locations

  • UCSF Medical Center Site Number : 107
    San Francisco California 94143 United States
  • MulitCare Institute for Research & Innovation Site Number : 103
    Tacoma Washington 98405 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Provention Bio, a Sanofi Company
ID
NCT05757713
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated