PROTECT Extension: Long term safety study of Teplizumab in Diabetes
Research type
Research Study
Full 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
IRAS ID
1004040
Contact name
Sharon Rowland
Contact email
Sponsor organisation
Provention Bio, Inc.
Eudract number
2020-002798-92
Clinicaltrials.gov Identifier
Research summary
This study will follow participants who previously completed the PROTECT study for 42 months (about 3½ years). The research is to find out more information about teplizumab, the new medicine that participants received in the PROTECT study.
The study will look at how safe teplizumab is long term and how well diabetes is managed.
This is an observational study, which means no study drug will be given to participants. Participants will continue to receive standard care for Type 1 Diabetes.
The last visit in the PROTECT study can be the first visit in this study. Or participants can join this study up to 6 months after the last visit in the PROTECT study. Participants will be required to visit the hospital every 6 months for a total of 7 visits.
Study assessments include physical examinations, vital signs (temperature, heart rate, respiratory rate, the rate at which breathing occurs, and blood pressure), blood and urine samples, a mixed meal tolerance test and a review of health status (side effects) and insulin use. The “mixed meal” is a special nutritional drink. It is used to see if the body is still able to make insulin.
Approximately 200 participants are anticipated to be enrolled in this study globally, with approximately 7 being enrolled at 2 sites in the UK.
The study is sponsored by Provention Bio, IncREC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0236
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion