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 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 and serologic response to vaccines and exploratory T1D clinical features will be explored.

Approximately 20 participants will be enrolled The regimen consists 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

Type 1 Diabetes, Stage 2 T1D, Pediatric T1D, 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

  • Clinical Site 107 accepting new patients
    San Francisco California 94143 United States
  • Clinical Site 103 accepting new patients
    Tacoma Washington 98405 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Provention Bio, Inc.
ID
NCT05757713
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated