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Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875729
Recruitment Status : Active, not recruiting
First Posted : March 15, 2019
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
Provention Bio, Inc.

Study Description
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Brief Summary:

The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Biological: teplizumab Biological: Placebo Phase 3

Detailed Description:

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis). Approximately 300 participants will be randomized at a ratio of 2:1 to either the teplizumab group or the placebo group.

Teplizumab or matching placebo will be administered in two courses 6 months apart. Each course of treatment will include daily infusions for 12 days. The total study duration for each participant will be up to 86 weeks.

The primary objective is to determine whether two courses of teplizumab administered 6 months apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.

The secondary objectives are to evaluate improvements in key clinical parameters of diabetes management, to determine the safety and tolerability of teplizumab, and to evaluate the pharmacokinetics (PK) and immunogenicity of teplizumab

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 3, randomized, double-blind, placebo-controlled, multinational, multicenter study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: teplizumab
Sterile solution for injection.
 Biological: teplizumab
Treatment
Placebo Comparator: Placebo
Sterile solution for injection
 Biological: Placebo
Control


Outcome Measures
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Primary Outcome Measures :
  1. The area under the time-concentration curve (AUC) of C-peptide after a mixed meal tolerance test (MMTT) at Week 78 [ Time Frame: Week 78 ]
    Clinical Endpoint


Secondary Outcome Measures :
  1. Exogenous insulin use [ Time Frame: Week 78 ]
    Clinical Endpoint

  2. HbA1c levels [ Time Frame: Week 78 ]
    Clinical Endpoint

  3. Time in glycemic target range [ Time Frame: Week 78 ]
    Clinical Endpoint

  4. Clinically important hypoglycemic episodes [ Time Frame: Week 78 ]
    Clinical Endpoint

  5. Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [ Time Frame: Up to Week 52 and Week 78 ]
    Safety Endpoint

  6. Teplizumab serum concentrations [ Time Frame: 78 Week ]
    PK Endpoint

  7. Incidence and titers of anti-teplizumab antibodies after treatment courses [ Time Frame: 78 Week ]
    Immunogenicity Endpoint


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
  2. Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
  3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
  4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
  5. Has a positive result on testing for T1D-related autoantibodies.

Exclusion Criteria:

  1. Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.
  2. Has an active infection and/or fever.
  3. 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).
  4. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875729


Locations
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Sponsors and Collaborators
Provention Bio, Inc.
Investigators
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Study Director: Chief Medical Officer, MD Provention Bio, Inc.
More Information
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Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT03875729    
Other Study ID Numbers: PRV-031-001
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Provention Bio, Inc.:
T1D, type 1 diabetes, recent-onset T1D
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases