Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)

Provention Bio, a Sanofi Company

Status and phase

Active, not recruiting

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Biological: teplizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05757713

SFY18116 (Other Identifier)

PRV-031-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 7 years old

Volunteers

No Healthy Volunteers

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.