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Teplizumab in Pediatric Stage 2 Type 1 Diabetes

NCT05757713 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

teplizumab

CD3-directed humanized monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2026-08-27
Completion
2026-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757713 on ClinicalTrials.gov