This study is currently not recruiting participants.

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Study on Investigational Medication for Pediatric 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.

This study investigates the safety and how the body processes an investigational medication in children who have Stage 2 Type 1 diabetes. Participants in the study will receive the investigational medication through an intravenous infusion once daily for 14 days. The study will check for any antibodies the body might develop against the medication. The safety, tolerability, and other clinical features related to Type 1 diabetes will be monitored and analyzed using descriptive statistics.

  • Who can participate: Children aged 0 to under 8 years with Stage 2 Type 1 diabetes, characterized by two related autoantibodies and dysglycemia, can participate. Participants must not have other autoimmune diseases, active infections, or a history of certain viral infections.
  • Study details: Participants will receive an intravenous infusion of the investigational medication daily for 14 days. The study will monitor how the body reacts to the medication and any potential development of antibodies against it.
  • Study timelines: The study will last up to approximately 26 months.
Updated on 05 Feb 2026. Study ID: NCT05757713