NCT04598893

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

A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 188 (actual)
• Sponsor: Provention Bio, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose. Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study. No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians. Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BIOLOGICAL	Teplizumab	Received teplizumab in PROTECT Study
OTHER	Placebo	Received placebo in PROTECT study

Timeline

• Start date: 2020-10-26
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2020-10-22
• Last updated: 2025-12-09

Locations

47 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study