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At-Risk for Type 1 Diabetes Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04270942
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):
Provention Bio, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: teplizumab Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, multicenter, open-label clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Teplizumab treated
Administration of teplizumab by intravenous infusion
Biological: teplizumab
anti-CD3 humanized monoclonal antibody
Other Name: PRV-031

Primary Outcome Measures :
  1. Safety and tolerability of teplizumab treatment [ Time Frame: 78 weeks ]
    Incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events

Secondary Outcome Measures :
  1. Pharmacokinetics of Teplizumab [ Time Frame: 78 weeks ]
    Levels of teplizumab in the serum

  2. Immunogenicity of Teplizumab [ Time Frame: 78 weeks ]
    Levels of anti-drug antibodies in the serum

  3. Loss of C-peptide Produced by Pancreatic Beta Cells in Individuals with Recent Diagnosis of type 1 diabetes [ Time Frame: 78 weeks ]
    area under the time-versus-concentration curve of C-peptide after a 4-hour mixed meal tolerance test, a measure of endogenous insulin production and beta cell function

  4. Clinical Parameter 1 of Diabetes Management [ Time Frame: 78 weeks ]
    HbA1c levels

  5. Clinical Parameter 2 of Diabetes Management [ Time Frame: 78 weeks ]
    insulin use

  6. Clinical Parameter 3 of Diabetes Management [ Time Frame: 78 weeks ]
    frequency of clinical important hypoglycemic episodes

  7. Change in T-cell Subpopulations [ Time Frame: 78 weeks ]
    Change in T-cell subpopulations analyzed by flow cytometry

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Previous participant in the TN-10 study
  2. 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).
  3. Participant is able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
  4. Participant is willing to forego other forms of experimental treatment during the entire study.
  5. Participant and/or guardian has given informed consent and assent as applicable.

Exclusion Criteria:

  1. Has an active infection and/or fever.
  2. 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).
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04270942

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Contact: Chief Medical Officer, MD 908-356-0514

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United States, Colorado
Clinical Site Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Provention Bio MD         
United States, Connecticut
Clinical Site Recruiting
New Haven, Connecticut, United States, 06519
Contact: Provention Bio MD         
United States, Florida
Clinical Site Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Provention Bio MD         
United States, Tennessee
Clinical Site Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Provention Bio MD         
United States, Washington
Clinical site Recruiting
Seattle, Washington, United States, 98101
Contact: Provention Bio, MD         
Sponsors and Collaborators
Provention Bio, Inc.
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Responsible Party: Provention Bio, Inc. Identifier: NCT04270942    
Other Study ID Numbers: PRV-031-002
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases