Status:
COMPLETED
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Lead Sponsor:
Provention Bio, Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-17 years
Phase:
PHASE3
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 p...
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 chil...
Eligibility Criteria
Inclusion
- Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
- Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association.
- Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
- Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
- Has a positive result on testing for T1D-related autoantibodies.
Exclusion
- Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.
- Has an active infection and/or fever.
- 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).
- 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.
Key Trial Info
Start Date :
April 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT03875729
Start Date
April 5 2019
End Date
May 1 2023
Last Update
April 24 2024
Active Locations (62)
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1
Rady Children's Hospital-San Diego (Site 004)
San Diego, California, United States, 92123
2
UCSF Medical Center (Site 001)
San Francisco, California, United States, 94158
3
Diablo Clinical Research, Inc. (Site 002)
Walnut Creek, California, United States, 94598
4
University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005)
Aurora, Colorado, United States, 80045