Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Investigating the Safety of an Investigational Medication in Young Children with Stage 2 Type 1 Diabetes

Not Recruiting
7 years or below
All
Phase 4
20 participants needed

Study Overview

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 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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus, Type 1
  • Age: 7 years or below
  • Gender: All

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.

Updated on 10 Feb 2025. Study ID: NCT05757713

This study investigates the safety and how the body processes an investigational medication in young children with Stage 2 type 1 diabetes. Stage 2 type 1 diabetes is when a person has two specific antibodies related to diabetes and shows signs of irregular blood sugar levels. The study focuses on children under 8 years old.

Participants will receive the investigational medication through an intravenous infusion once a day for 14 days. Researchers will also check for any antibodies the body might make against the medication. The study will use descriptive statistics to summarize safety, tolerability, and other data collected.

  • Who can participate: Children under 8 years old with Stage 2 type 1 diabetes, characterized by two diabetes-related antibodies and irregular blood sugar levels, are eligible.
  • Study details: Participants will receive an investigational medication through an intravenous infusion once daily for 14 days, and researchers will monitor for antibody development against the medication.
  • Study timelines: The study will last up to approximately 26 months.