Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)
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:
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Conditions:
Diabetes Mellitus, Type 1
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Age: - 7 Years
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Gender: All
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
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