for people ages 9-18 (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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.

Official Title

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


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.


Type 1 Diabetes Mellitus, T1D, type 1 diabetes, recent-onset type 1 diabetes, teplizumab, Diabetes Mellitus, Teplizumab


You can join if…

Open to people ages 9-18

  1. 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.
  2. 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.

You CAN'T join if...

1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.


  • UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)
    San Francisco California 94158 United States
  • Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)
    Walnut Creek California 945981 United States


accepting new patients by invitation only
Start Date
Completion Date
Provention Bio, Inc.
Study Type
Expecting 200 study participants
Last Updated