MedTrace Logo

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

NCT04598893 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 188

Last updated 2025-12-09

No results posted yet for this study

Summary

The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Teplizumab

Received teplizumab in PROTECT Study

OTHER

Placebo

Received placebo in PROTECT study

Sponsors & Collaborators

  • Provention Bio, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
9 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

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 NCT04598893 on ClinicalTrials.gov