An observational study in Diabetes Mellitus, Type 1, sponsored by Provention Bio, a Sanofi Company. Active, not recruiting at 47 sites in 8 countries. Open to participants aged 9 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Provention Bio, a Sanofi Company · Observational
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 188 is above the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Provention Bio, a Sanofi Company is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who completed the PROTECT (PRV-031-001) study
Exclusion Criteria:
1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Participants who received teplizumab in the PROTECT study
Biological: Teplizumab
Participants who received placebo in the PROTECT study
Other: Placebo
Received teplizumab in PROTECT Study
Received placebo in PROTECT study
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
Safety outcome
Time frame: During 42 months of follow-up
Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT)
Clinical parameters of diabetes management 1
Time frame: During the 42 months of follow-up
Insulin use (daily average insulin dose in U/kg/day)
Clinical parameters of diabetes management 2
Time frame: During the 42 months of follow-up
HbA1c
Clinical parameters of diabetes management 3
Time frame: During the 42 months of follow-up
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Provention Bio, a Sanofi Company