Back to resultsAt-Risk for Type 1 Diabetes Extension Study
Primary Purpose
Diabetes Mellitus, Type 1
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
teplizumab
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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.
Sites / Locations
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teplizumab treated
Arm Description
Administration of teplizumab by intravenous infusion
Outcomes
Primary Outcome Measures
Safety and tolerability of teplizumab treatment
Incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events
Secondary Outcome Measures
Pharmacokinetics of Teplizumab
Levels of teplizumab in the serum
Immunogenicity of Teplizumab
Levels of anti-drug antibodies in the serum
Loss of C-peptide Produced by Pancreatic Beta Cells in Individuals with Recent Diagnosis of type 1 diabetes
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
Clinical Parameter 1 of Diabetes Management
HbA1c levels
Clinical Parameter 2 of Diabetes Management
insulin use
Clinical Parameter 3 of Diabetes Management
frequency of clinical important hypoglycemic episodes
Change in T-cell Subpopulations
Change in T-cell subpopulations analyzed by flow cytometry
Full Information
NCT ID
NCT04270942
First Posted
February 10, 2020
Last Updated
August 13, 2023
Sponsor
Provention Bio, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04270942
Brief Title
At-Risk for Type 1 Diabetes Extension Study
Official Title
An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provention Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, multicenter, open-label clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teplizumab treated
Arm Type
Experimental
Arm Description
Administration of teplizumab by intravenous infusion
Intervention Type
Biological
Intervention Name(s)
teplizumab
Other Intervention Name(s)
PRV-031
Intervention Description
anti-CD3 humanized monoclonal antibody
Primary Outcome Measure Information:
Title
Safety and tolerability of teplizumab treatment
Description
Incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events
Time Frame
78 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics of Teplizumab
Description
Levels of teplizumab in the serum
Time Frame
78 weeks
Title
Immunogenicity of Teplizumab
Description
Levels of anti-drug antibodies in the serum
Time Frame
78 weeks
Title
Loss of C-peptide Produced by Pancreatic Beta Cells in Individuals with Recent Diagnosis of type 1 diabetes
Description
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
Time Frame
78 weeks
Title
Clinical Parameter 1 of Diabetes Management
Description
HbA1c levels
Time Frame
78 weeks
Title
Clinical Parameter 2 of Diabetes Management
Description
insulin use
Time Frame
78 weeks
Title
Clinical Parameter 3 of Diabetes Management
Description
frequency of clinical important hypoglycemic episodes
Time Frame
78 weeks
Title
Change in T-cell Subpopulations
Description
Change in T-cell subpopulations analyzed by flow cytometry
Time Frame
78 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Clinical Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Clinical Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Clinical Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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At-Risk for Type 1 Diabetes Extension Study
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