At-Risk for Type 1 Diabetes Extension Study

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Provention Bio, Inc.
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Updated on 19 February 2024
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diabetes
type 1 diabetes mellitus
teplizumab

Summary

This study is an extension of the NIH-sponsored AT-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who develop clinical type 1 diabetes after the conclusion of that trial, are eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

Description

The study is a single-arm, multicenter, open-label clinical trial. All participants will receive a 12-day course of teplizumab given through daily IV infusion and will be followed for 78 weeks.

The purpose of this study is to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (IV) to participants in the NIH-sponsored trial who have developed type 1 diabetes and are able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduces the loss of insulin-producing pancreatic beta cells will also be evaluated.

Details
Condition Insulin dependent diabetes mellitus
Age 100years or below
Treatment teplizumab
Clinical Study IdentifierNCT04270942
SponsorProvention Bio, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Previous participant in the TN-10 study
Participant has received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA)
Participant is able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis
Participant is willing to forego other forms of experimental treatment during the entire study
Participant and/or guardian has given informed consent and assent as applicable

Exclusion Criteria

Has an active infection and/or fever
Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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