Summary

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

Description

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.

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

Details

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.

Keywords

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

Eligibility

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.

Locations

  • 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

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Provention Bio, Inc.
ID
NCT04598893
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated