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Advice for people with diabetes and their families

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PROTECTing insulin-producing cells in children newly diagnosed with type 1

August 2020
July 2021
England & Wales
Provention Bio, Inc
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

The PROTECT study is testing how well an investigational medicine, called teplizumab, works in children and adolescents with type 1 diabetes. Teplizumab is an immunotherapy. It works by retraining the immune system to halt its attack against the pancreas, so that it no longer destroys insulin-producing cells.

If you or your child are 8–17 years old and have recently been diagnosed with type 1 diabetes in the last six weeks you may be able to take part. Other medical criteria must be met before you can join the study, which will be assessed by the study team.

If you or your child are eligible to take part, you'll be placed into one of two study treatment groups. Two thirds of participants will be assigned to the Teplizumab group and one third will be assigned to the placebo group. This is decided at random, like drawing straws. Neither you, your child, nor the study doctor will know to which study treatment group you or your child have been assigned. This ensures that the results from the different groups will be handled in the same way.

You or your child will receive two courses of the medicine over the duration of the study. Both the investigational medicine and placebo are given by intravenous (IV) infusion. This means a needle will be inserted into a vein, usually in the arm, and the liquid medication supplied continuously.

In this study, the IV infusion is given daily for a period of 12 days on two separate occasions, six months apart; the infusions will usually last for about 30 minutes. 

The hospitals listed below are participating in the study, although not all sites are currently open:

  • University Hospitals of Leicester NHS Trust
  • Cardiff & Vale University Local Health Board
  • Sheffield Children’s NHS Foundation Trust
  • London North West University Healthcare NHS Trust

If you are interested in taking part or want more information please go to the Type 1 Diabetes UK Immunotherapy Consortium.

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