Protect Study

Sites are now beginning to re-open to recruitment for trials on a staggered site by site basis.

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).

Open to recruitment

  • Sheffield Children’s NHS Foundation Trust

Temporary Closed

  • University Hospitals of Leicester NHS Trust
  • Cardiff & Vale University Local Health Board
  • London North West University Healthcare NHS Trust
  • Southampton University Hospitals NHS Trust

Summary

The PROTECT Study is testing how well an investigational medicine works in children and adolescents with Type 1 diabetes (T1D). If you or your child are 8–17 years old and have recently been diagnosed with T1D 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.

Aim

The PROTECT Study will assess how well an investigational medicine, called teplizumab, works in children and adolescents recently diagnosed with Type 1 diabetes (T1D). ‘Investigational’ means that the medicine has not been approved for the treatment of T1D and is still being evaluated in clinical studies such as this one. The investigational medicine will be compared with a placebo—a substance that looks like teplizumab but contains no real treatment. The PROTECT Study will also assess whether there are any side effects from taking the investigational medicine.

If you are interested in taking part, please click the “Get Involved” button below:

Eligibility to take part

  1. Age 8-17 years old
  2. Diagnosed with T1D in the previous 6 weeks
  3. Positive for 1 of 5 T1D autoantibodies (test to be done as part of the study)
  4. Ability to produce a minimum amount of your own insulin (test to be done as part of study)
  5. Otherwise generally healthy, with no other significant medical conditions, recent or history of infections or taking medicines that might interfere with teplizumab

What will I be asked to do?

If you or your child are eligible to take part in the PROTECT Study, you or your child will 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 study 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, 6 months apart; the infusions will usually last for about 30 minutes. Further details of how and when to take the investigational medicine or placebo will be given by the study team.

Who is running this study?

This research study is being conducted and funded by Provention Bio, Inc. The hospitals listed below are participating in the study:

  • 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
  • Southampton University Hospitals NHS Trust

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