At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270942
• Other study ID #: PRV-031-002
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2020
• Est. completion date: January 22, 2024

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 22, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Biological:
• teplizumab
anti-CD3 humanized monoclonal antibody

Locations

Country	Name	City	State
United States	Clinical Site	Aurora	Colorado
United States	Clinical Site	Gainesville	Florida
United States	Clinical Site	Nashville	Tennessee
United States	Clinical Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of teplizumab treatment	Incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events	78 weeks
Secondary	Pharmacokinetics of teplizumab	Levels of teplizumab in the serum	78 weeks
Secondary	Immunogenicity of Teplizumab	Levels of anti-drug antibodies in the serum	78 weeks
Secondary	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	78 weeks
Secondary	Clinical Parameter 1 of Diabetes Management	HbA1c levels	78 weeks
Secondary	Clinical Parameter 2 of Diabetes Management	Insulin use	78 weeks
Secondary	Clinical Parameter 3 of Diabetes Management	Frequency of clinical important hypoglycemic episodes	78 weeks
Secondary	Change in T-cell Subpopulations	Change in T-cell subpopulations analyzed by flow cytometry	78 weeks