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A Study of Long-Term Safety of Teplizumab in Children and Adolescents with Recently Diagnosed Type 1 Diabetes

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children and adolescents with Type 1 Diabetes Mellitus, a condition where the body's immune system attacks and destroys cells in the pancreas that produce insulin. The study will evaluate a medicine called teplizumab, which is given as a concentrated solution through an intravenous infusion. This medication is a type of antibody that targets specific cells in the immune system.

The purpose of this research is to understand the long-term safety of teplizumab in young patients who have recently been diagnosed with Type 1 Diabetes Mellitus and who previously participated in an earlier study of this medication. The study will monitor these patients for an additional 42 months after their completion of the previous trial.

During the study, participants will receive teplizumab through an infusion into their veins. The medication will be given at a dose based on the patient's body size. Throughout the study, doctors will monitor the participants' health, including how well their body produces insulin and their blood sugar control. They will also track any side effects that may occur during or after the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment

    After completing the previous PROTECT study, you can join this extension study that will last for an additional 42 months (3.5 years).

    The study focuses on monitoring the long-term safety of teplizumab, a medication for type 1 diabetes.

  2. Step 2

    Treatment administration

    You will receive teplizumab through an intravenous infusion (delivered directly into your vein).

    The medication comes in the form of a concentrate that is diluted into a solution for the infusion.

  3. Step 3

    Regular monitoring visits

    Throughout the study, your health will be closely monitored for any side effects or health changes.

    The medical team will track and record any adverse events that may occur during your participation.

    You will undergo mixed-meal tolerance tests (a test that measures your body's insulin production).

    Your daily insulin use will be recorded and measured in units per kilogram per day.

    Regular measurements of your HbA1c levels (a blood test that shows average blood sugar levels) will be taken.

  4. Step 4

    Study completion

    The study is expected to continue until October 2026.

    Your participation will help evaluate how safe teplizumab is when used over an extended period in children and adolescents with type 1 diabetes.

Who can join the trial?

7 criteria

  • Must have completed the PRV-031-001 (PROTECT) study through Week 78 visit, regardless of how many doses of study medication were received
  • Must provide written informed consent within 12 months after completing Week 78 of the previous PROTECT study
  • For participants under 18 years of age, written assent (agreement to participate) must be obtained according to applicable regulations
  • Both male and female participants can join the study
  • Must be either:
    • An adolescent (12-17 years old)
    • An adult (18 years and older)
    • Must have previously participated in the original PROTECT study investigating teplizumab (an experimental medication for Type 1 Diabetes)

Who cannot join the trial?

11 criteria

  • Current pregnancy or plans to become pregnant during the study period (pregnancy test required for women of childbearing age)
  • Presence of any serious medical condition that could interfere with the study procedures or participant safety
  • Did not complete the previous PRV-031-001 (PROTECT) study
  • Known allergic reactions to teplizumab or similar medications
  • Active infections or major illnesses that could affect study participation
  • Use of other experimental drugs or participation in other clinical trials within the past 30 days
  • Significant kidney or liver problems (as determined by blood tests)
  • History of severe allergic reactions to medications
  • Inability to follow study procedures or attend scheduled visits
  • Mental conditions that could affect the ability to provide informed consent
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Teplizumab (also known as PRV-031) is a humanized antibody medication that targets a protein called CD3 on immune cells. It is designed to help people with recently diagnosed Type 1 diabetes by modifying the immune system's response. The medication works by attempting to preserve the body's ability to produce insulin by preventing the immune system from attacking insulin-producing cells in the pancreas. This treatment is being studied specifically in children and adolescents who have been recently diagnosed with Type 1 diabetes.

What is already known about the treatment

Teplizumab - A humanized monoclonal antibody administered intravenously that targets the CD3 receptor on T cells, being investigated as a potential treatment for Type 1 Diabetes Mellitus. This medication works by modifying the immune system's response, specifically by interfering with T cells that are responsible for destroying insulin-producing beta cells in the pancreas, potentially slowing down or preventing the progression of early-stage Type 1 diabetes. As an immunomodulating agent, teplizumab represents a novel approach in diabetes treatment, focusing on the underlying autoimmune process rather than just managing symptoms, and has shown promising results in clinical trials for delaying the onset of Type 1 diabetes in high-risk individuals.

Investigated diseases

Type 1 Diabetes Mellitus – A chronic condition where the body's immune system attacks and destroys insulin-producing cells in the pancreas. This results in little to no insulin production, preventing cells from properly using glucose from food for energy. The condition typically develops during childhood or adolescence, though it can occur at any age. People with this condition experience high blood sugar levels and need to carefully monitor their glucose. The body's inability to produce insulin leads to various metabolic changes and requires regular blood sugar management. Without proper insulin, the body begins to break down fat and muscle for energy, leading to various metabolic changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516543-26-00Protocol codePRV-031-003/LTS18119Estimated enrolment188 patientsSponsorProvention Bio Inc.

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