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Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

NCT03875729 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2024-04-24

Study results available
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Summary

The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

teplizumab

Treatment

BIOLOGICAL

Placebo

Control

Sponsors & Collaborators

  • Provention Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer, MD · Provention Bio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2023-05-01
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03875729 on ClinicalTrials.gov