Provention Bio's T1D Trial Evaluating C-Peptide with Teplizumab
Research type
Research Study
Full title
A Phase 3, Randomised, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanised, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D)
IRAS ID
262945
Contact name
Pradnya Lokhande
Contact email
Sponsor organisation
Provention Bio, Inc
Eudract number
2018-004926-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
100262, US IND
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
This study is being carried out to evaluate if Teplizumab (an investigational drug) can help improve the control of sugar in the blood by slowing down the loss of the body’s cells (β cell) that produce insulin and maintaining their function.
Type 1 Diabetes (T1D) is a T cell- mediated autoimmune disease that targets and destroys β cells . The loss of these cells results in the body’s inability to sense glucose levels and produce insulin. Teplizumab is an antibody that binds to the T cell receptor, which are cells that are instrumental in initiating and coordinating the autoimmune process responsible for T1D. A number of studies have demonstrated the ability of teplizumab to slow or even halt the destruction of the insulin secreting β cells in populations of newly diagnosed T1D.
This is a phase 3 randomised, double- blind (neither the study doctor or patient will know which treatment they are assigned), placebo- (looks like the study drug but does not contain any active ingredients) controlled study. A total of 300 children and adolescents (between 8-17 years old) will be recruited in this study in approximately 90 sites in North America and Europe.
Patients will be randomised (assigned by chance, like flipping a coin) to either the study drug or placebo.
There will be 2 treatment courses in this study. Each treatment course will be 12 days, 6 months apart and the study will have a post-treatment observation period of approximately 1 year.The study is sponsored by Provention Bio, Inc.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0966
Date of REC Opinion
26 Jul 2019
REC opinion
Further Information Favourable Opinion