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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Biological: teplizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chief Medical Officer, MD; Phone Number: 908-356-0514; Email: eramos@proventionbio.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Clinical Site
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Clinical Site
  • Florida
    • Gainesville, Florida, United States, 32610
      • Clinical Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teplizumab treated; Administration of teplizumab by intravenous infusion	Biological: teplizumab; anti-CD3 humanized monoclonal antibody; Other Names: PRV-031

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of teplizumab treatment	Incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events	78 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of Teplizumab	Levels of anti-drug antibodies in the serum	78 weeks
Clinical Parameter 1 of Diabetes Management	HbA1c levels	78 weeks
Change in T-cell Subpopulations	Change in T-cell subpopulations analyzed by flow cytometry	78 weeks
Pharmacokinetics of teplizumab	Levels of teplizumab in the serum	78 weeks
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
Clinical Parameter 2 of Diabetes Management	Insulin use	78 weeks
Clinical Parameter 3 of Diabetes Management	Frequency of clinical important hypoglycemic episodes	78 weeks

Collaborators and Investigators

• Sponsor: Provention Bio, Inc.
• Investigators: Study Director: Global Project Head, Provention, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Type 1 diabetes; T1D; Teplizumab; New onset type 1 diabetes; Stage 3; Recent-onset type 1 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: PRV-031-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No