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Completed

NCT Number: NCT04270942

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barbara Davis Center for Diabetes Site Number : 04, Aurora, Colorado, United States

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About this study

The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks.

The purpose of this study was 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 were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: PRV-031, Tzield

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)

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

    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.

Secondary outcomes

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

    Time frame: Pre-dose on Day 364

    Blood samples were collected for evaluation of pharmacokinetic (PK) data.

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

    Time frame: Up to Day 364

    Blood samples were collected for the evaluation of ADA against teplizumab.

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

    Time frame: Week 78

    The AUC of C-peptide was measured after a 4-hour MMTT as a measure of assessing endogenous insulin production and beta cell function. The AUC was computed using the trapezoidal rule and standardized by the duration of the MMTT test for the analysis.

  4. Glycated Hemoglobin (HbA1c) Levels at Week 78

    Time frame: Week 78

    Blood samples were collected for evaluation of HbA1c.

  5. Average Daily Use of Exogenous Insulin at Week 78

    Time frame: Week 78

    The average daily insulin use was calculated based on participants who had at least 3 days of insulin use recorded in the diary for the Week 78 visit.

  6. Number of Participants With Severe Hypoglycemic Episodes

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

    The severity of a hypoglycemia event was identified by the Investigator and classified according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 as follows:

    • Grade 3 hypoglycemia: 30-39 milligram/deciliter (mg/dL) (1.7-2.1 millimole [mmol]/L). This is considered severe or medically significant but not immediately life-threatening. Hospitalization or prolongation of hospitalization is likely indicated. It is considered disabling and limits self-care.
    • Grade 4 hypoglycemia: <=29 mg/dL (1.6 mmol/L). This is considered life threatening (seizures) with urgent intervention indicated.
    • Grade 5 hypoglycemia: Hypoglycemia resulting in death. Hypoglycemia >=Grade 3 was considered as severe hypoglycemia.

  7. Number of Participants With Change in Cluster of Differentiation (CD)8+ TIGIT+ KLRG1+ T Cells

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

    CD8+ TIGIT+ KLRG1+ T cells were measured using flow cytometry.

Sponsors and collaborators

Lead sponsor

Provention Bio, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2020
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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