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NCT03875729 · ClinicalTrials.gov registry record · Phase 3
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Provention Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
- 20
- Study locations
NCT03875729 is a Phase 3 study of Type 1 Diabetes Mellitus that has completed, run by Provention Bio. The registered enrollment target is 328 participants, above the 137-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (139% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT03875729, a Phase 3 study of Type 1 Diabetes Mellitus, has completed, sponsored by Provention Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL teplizumab
Study Locations (20)
Florida
- UF Clinical and Translation Research Building (Site 015) - Gainesville
- Nemours Children's Specialty Care-Endocrinology (Site 047) - Jacksonville
- University of Miami Health System (Site 028) - Miami
- All Children's Hospital-Johns Hopkins Medicine (Site 048) - St. Petersburg
- University of South Florida Diabetes and Endocrinology Center (Site 011) - Tampa
California
- Rady Children's Hospital-San Diego (Site 004) - San Diego
- UCSF Medical Center (Site 001) - San Francisco
- Diablo Clinical Research, Inc. (Site 002) - Walnut Creek
Georgia
- Atlanta Diabetes Associates (Site 009) - Atlanta
- Centricity Research (Site 006) - Columbus
Idaho
- St. Luke's Children's Endocrinology (Site 052) - Boise
- Rocky Mountain Diabetes and Osteoporosis Center (Site 007) - Idaho Falls
Colorado
- University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005) - Aurora
Connecticut
- Yale University of Medicine (Site 020) - New Haven
Illinois
- University of Chicago Medical Center (Site 017) - Chicago
Indiana
- Indiana University Hospital and Riley Hospital for Children (Site 014) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03875729
The ClinicalTrials.gov registry entry for NCT03875729 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 137-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (139% higher). The listed sponsor is Provention Bio, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03875729 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03875729 about?
NCT03875729 is a clinical study titled "Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab". 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 mon...
What is the current status of trial NCT03875729?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2019-04-05. Estimated completion is 2023-05-01.
What conditions does trial NCT03875729 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03875729?
The interventions under investigation include: Placebo (BIOLOGICAL), teplizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03875729?
This trial is sponsored by Provention Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03875729 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.