Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Phase 4Active Not RecruitingNCT05757713

Sanofi20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

teplizumabBIOLOGICAL

CD3-directed humanized monoclonal antibody

Eligibility

Sex: ALLMin age: 0 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (10)

UCSF Medical Center Site Number : 107

San Francisco, California, United States

Barbara Davis Center for Diabetes Site Number : 102

Aurora, Colorado, United States

Yale University School of Medicine Site Number : 101

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

Safety and tolerability endpoint

Time frame: Through 104 Weeks

Secondary Outcomes

Serum concentrations of teplizumab

Pharmacokinetic (PK) endpoint

Time frame: Sparse PK samples between Days 1 and 28

Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab)

Immunogenicity endpoint

Time frame: Through 104 weeks

CD3 receptor occupancy

To assess the effects of teplizumab on cluster of differentiation 3 (CD3) receptor occupancy

Time frame: Days 1 and 9

Data from ClinicalTrials.gov

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