Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
NCT03875729 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Provention Bio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03875729 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03875729?
The interventions under investigation include: Placebo (BIOLOGICAL), teplizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03875729?
This trial is sponsored by Provention Bio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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