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

NCT04270942 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: PRV-031-002SFY18115
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 8

Brief Summary

This study was 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 developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1

Keywords

Recent-onset type 1 diabetes; Teplizumab; T1D; Stage 3; Type 1 diabetes; New onset type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Adverse Events of Special Interest (TEAESIs) and Treatment-emergent Serious Adverse Events (TESAEs)

  An AE was any untoward medical occurrence in a participant or clinical study participant,temporally associated with use of study dose,whether or not considered related to study dose.AESI was any AE that met any of following:All \>=Grade 3 infections (including all opportunistic infections);acute mononucleosis-like illness;lymphomas or other malignancies;severe hypoglycemic episode;\>=Grade 3 liver function abnormalities, thrombocytopenia, neutropenia or rash;\>= Grade 4 allergic/hypersensitivity reaction (anaphylaxis) or cytokine-release syndrome; lymphocyte count \<500/cubic millimeter for 7 days or longer. An SAE was as any untoward medical occurrence that,at any dose:resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization,resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or any other medically important event.A TEAE was any AE which started during or after the first dose of teplizumab.

  From the first dose of study drug administration (Day 1) up to approximately 78 weeks

Secondary Outcomes (7)

• Serum Concentration Immediately Prior to Administration of the Next Dose (Ctrough) of Teplizumab at Day 364

  Pre-dose on Day 364

• Number of Participants With Anti-drug Antibodies (ADA) Against Teplizumab

  Up to Day 364

• Area Under the Time-Versus-Concentration Curve (AUC) of C-peptide After a 4-hour (4h) Mixed Meal Tolerance Test (MMTT) at Week 78

  Week 78

• Glycated Hemoglobin (HbA1c) Levels at Week 78

  Week 78

• Average Daily Use of Exogenous Insulin at Week 78

  Week 78

Study Arms (1)

Teplizumab treated

EXPERIMENTAL

Administration of teplizumab by intravenous infusion for 12 consecutive days

Drug: teplizumab 1 mg/mL

Interventions

teplizumab 1 mg/mL DRUG

Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody). Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily

Also known as: PRV-031, Tzield

Teplizumab treated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Had an active infection and/or fever.
• Had 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 had a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.

Sponsors & Collaborators

• Provention Bio, a Sanofi Company: lead

Study Sites (8)

Barbara Davis Center for Diabetes Site Number : 04

Aurora, Colorado, 80045, United States

Location

Clinical Site

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine Site Number : 01

New Haven, Connecticut, 06511, United States

Location

Clinical Site

New Haven, Connecticut, 06519, United States

Location

Clinical Site

Gainesville, Florida, 32610, United States

Location

University of Florida Site Number : 02

Gainesville, Florida, 32610, United States

Location

Clinical Site

Nashville, Tennessee, 37232, United States

Location

Vanderbilt Univerity Medical Center Site Number : 03

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

teplizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, multicenter, open-label clinical trial

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: February 26, 2020
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (8)