Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Completed · Phase 3 · Has a placebo group
Conditions studied: Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03875729
- Run by
- Provention Bio, Inc.
- People needed
- 328
- Starts
- 2019-04-05
- Expected to finish
- 2023-05-01
- Last updated by the study team
- 2024-04-24
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCSF Medical Center (Site 001) — San Francisco, California, United States
- Diablo Clinical Research, Inc. (Site 002) — Walnut Creek, California, United States
- University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005) — Aurora, Colorado, United States
- Yale University of Medicine (Site 020) — New Haven, Connecticut, United States
- UF Clinical and Translation Research Building (Site 015) — Gainesville, Florida, United States
- Nemours Children's Specialty Care-Endocrinology (Site 047) — Jacksonville, Florida, United States
- University of Miami Health System (Site 028) — Miami, Florida, United States
- All Children's Hospital-Johns Hopkins Medicine (Site 048) — St. Petersburg, Florida, United States
- University of South Florida Diabetes and Endocrinology Center (Site 011) — Tampa, Florida, United States
- Atlanta Diabetes Associates (Site 009) — Atlanta, Georgia, United States
- Centricity Research (Site 006) — Columbus, Georgia, United States
- St. Luke's Children's Endocrinology (Site 052) — Boise, Idaho, United States
- Rocky Mountain Diabetes and Osteoporosis Center (Site 007) — Idaho Falls, Idaho, United States
- University of Chicago Medical Center (Site 017) — Chicago, Illinois, United States
- Indiana University Hospital and Riley Hospital for Children (Site 014) — Indianapolis, Indiana, United States
- U. Iowa Children's Hospital (Site 023) — Iowa City, Iowa, United States
- Capital Diabetes & Endocrine Associates (Site 029) — Camp Springs, Maryland, United States
- Baystate Pediatric Endocrinology & Diabetes (Site 040) — Springfield, Massachusetts, United States
- U. Minnesota Health Clinical Research Unit (Site 031) — Minneapolis, Minnesota, United States
- Children's Mercy Hospitals & Clinics (Site 026) — Kansas City, Missouri, United States
- Washington University School of Medicine (Site 018) — St Louis, Missouri, United States
- Women and Children's Hospital of Buffalo (Site 010) — Buffalo, New York, United States
- UNC Hospitals Children's Specialty Clinic (Site 038) — Chapel Hill, North Carolina, United States
- Rainbow Babies & Children's Hospital (Site 049) — Cleveland, Ohio, United States
- Rady Children's Hospital-San Diego (Site 004) — San Diego, California, United States
Full record on ClinicalTrials.gov
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