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

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ClinicalTrials.gov Identifier: NCT03875729
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Provention Bio, Inc.

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


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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 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: teplizumab
Sterile solution for injection.
Biological: teplizumab
Treatment

Placebo Comparator: Placebo
Sterile solution for injection
Biological: Placebo
Control




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



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.

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


Contacts
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Contact: Chief Medical Officer, MD 908-356-0514 eramos@proventionbio.com

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Locations
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United States, California
Clinical Site 004 Recruiting
San Diego, California, United States, 92123
Clinical Site 001 Recruiting
San Francisco, California, United States, 94158
Clinical Site 002 Recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Clinical Site 005 Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Clinical Site 020 Recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Clinical Site 029 Recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
Clinical Site Not yet recruiting
Gainesville, Florida, United States, 32610
Clinical Site 028 Recruiting
Miami, Florida, United States, 33136
Clinical Site 011 Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Clinical Site 009 Recruiting
Atlanta, Georgia, United States, 30318
Clinical Site 006 Recruiting
Columbus, Georgia, United States, 31904
United States, Idaho
Clinical Site 007 Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Clinical Site 017 Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Clinical Site 014 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
Clinical site 023 Recruiting
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Clinical Site Not yet recruiting
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Clinical Site Not yet recruiting
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Clinical Site 026 Recruiting
Kansas City, Missouri, United States, 64108
Clinical Site 018 Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Clinical Site 010 Recruiting
Buffalo, New York, United States, 14203
Clinical Site Not yet recruiting
New York, New York, United States, 10029
United States, Ohio
Clinical Site Not yet recruiting
Columbus, Ohio, United States, 43205
United States, Oregon
Clinical Site 034 Recruiting
Bend, Oregon, United States, 97702
United States, Pennsylvania
Clinical Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Clinical Site 013 Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Clinical Site 008 Recruiting
Bartlett, Tennessee, United States, 38133
Clinical Site 024 Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Clinical site Not yet recruiting
Dallas, Texas, United States, 75235
United States, Washington
Clinical Site 016 Recruiting
Seattle, Washington, United States, 98101
Clinical Site 003 Recruiting
Tacoma, Washington, United States, 98405
Canada, British Columbia
Clinical Site 102 Recruiting
Vancouver, British Columbia, Canada
United Kingdom
Clinical Site 903 Recruiting
Sheffield, United Kingdom
Sponsors and Collaborators
Provention Bio, Inc.
Investigators
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Study Director: Provention Bio, MD Provention Bio, Inc.

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Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT03875729     History of Changes
Other Study ID Numbers: PRV-031-001
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: November 2019
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