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

Study Overview
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Brief Summary
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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
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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). Approximately 300 participants will be randomized at a ratio of 2:1 to the teplizumab or placebo and will receive two courses of treatment administered 6 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 6 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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Biological: Teplizumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered. Provide written informed consent within 6 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study. Exclusion Criteria: 1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Teplizumab<br>Participants who received teplizumab in the PROTECT study | Biological: Teplizumab<br>* Received teplizumab in PROTECT Study<br>|
| Placebo<br>Participants who received placebo in the PROTECT study | Other: Placebo<br>* Received placebo in PROTECT study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies. | Safety endpoints will be presented descriptively | 42 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1D, type 1 diabetes, recent-onset type 1 diabetes, teplizumab