Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Public ClinicalTrials.gov record NCT03875729. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03875729
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 328 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 5, 2019 (Actual)
- Primary completion
- May 1, 2023 (Actual)
- Completion
- May 1, 2023 (Actual)
- Last update posted
- Apr 24, 2024
2019 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rady Children's Hospital-San Diego (Site 004) | San Diego | California | 92123 | — |
| UCSF Medical Center (Site 001) | San Francisco | California | 94158 | — |
| Diablo Clinical Research, Inc. (Site 002) | Walnut Creek | California | 94598 | — |
| University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005) | Aurora | Colorado | 80045 | — |
| Yale University of Medicine (Site 020) | New Haven | Connecticut | 06520 | — |
| UF Clinical and Translation Research Building (Site 015) | Gainesville | Florida | 32610 | — |
| Nemours Children's Specialty Care-Endocrinology (Site 047) | Jacksonville | Florida | 32207 | — |
| University of Miami Health System (Site 028) | Miami | Florida | 33136 | — |
| All Children's Hospital-Johns Hopkins Medicine (Site 048) | St. Petersburg | Florida | 33701 | — |
| University of South Florida Diabetes and Endocrinology Center (Site 011) | Tampa | Florida | 33612 | — |
| Atlanta Diabetes Associates (Site 009) | Atlanta | Georgia | 30318 | — |
| Centricity Research (Site 006) | Columbus | Georgia | 31904 | — |
| St. Luke's Children's Endocrinology (Site 052) | Boise | Idaho | 82712 | — |
| Rocky Mountain Diabetes and Osteoporosis Center (Site 007) | Idaho Falls | Idaho | 83404 | — |
| University of Chicago Medical Center (Site 017) | Chicago | Illinois | 60637 | — |
| Indiana University Hospital and Riley Hospital for Children (Site 014) | Indianapolis | Indiana | 46202 | — |
| U. Iowa Children's Hospital (Site 023) | Iowa City | Iowa | 52242 | — |
| Capital Diabetes & Endocrine Associates (Site 029) | Camp Springs | Maryland | 20746 | — |
| Baystate Pediatric Endocrinology & Diabetes (Site 040) | Springfield | Massachusetts | 01199 | — |
| U. Minnesota Health Clinical Research Unit (Site 031) | Minneapolis | Minnesota | 55454 | — |
| Children's Mercy Hospitals & Clinics (Site 026) | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine (Site 018) | St Louis | Missouri | 63110 | — |
| Women and Children's Hospital of Buffalo (Site 010) | Buffalo | New York | 14203 | — |
| UNC Hospitals Children's Specialty Clinic (Site 038) | Chapel Hill | North Carolina | 27599 | — |
| Rainbow Babies & Children's Hospital (Site 049) | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic (Site 051) | Cleveland | Ohio | 44195 | — |
| Endocrinology Service Northwest, LLC (Site 034) | Bend | Oregon | 97702 | — |
| Childrens Hospital of Philadelphia - Endocrinology (Site 021) | Philadelphia | Pennsylvania | 19104 | — |
| Sanford Diabetes and Thyroiid Clinical (Site 013) | Sioux Falls | South Dakota | 57105 | — |
| AM Diabetes & Endocrinology Center (Site 008) | Bartlett | Tennessee | 38133 | — |
| Vanderbilt University Medical Center (Site 024) | Nashville | Tennessee | 37232 | — |
| Children's Medical Center Dallas (Site 033) | Dallas | Texas | 75235 | — |
| Benaroya Research Institute at Virginia Mason (Site 016) | Seattle | Washington | 98101 | — |
| MultiCare Institute for Research & Innovation (Site 003) | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03875729, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2024 · Synced Nov 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03875729 live on ClinicalTrials.gov.