Active — Not RecruitingPhase 4

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

United States20 participantsStarted 2023-07-25

Plain-language 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.

Who can participate

Age range0 Years – 7 Years

SexALL

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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.

What they're measuring

Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)

Timeframe: Through 104 Weeks

Trial details

NCT IDNCT05757713

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-27

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials