Study Details
Testing the Drug Teplizumab in Children and Young Adults Recently Diagnosed with Stage 3 Type 1 Diabetes
(IRB#: IRB_00189724)
This study will test a drug called Teplizumab to see if it will help young adults, adolescents, and children recently diagnosed with Stage 3 Type 1 Diabetes. Teplizumab was FDA-approved to delay the onset of Stage 3 Type 1 Diabetes. The study wants to see if the drug will also help patients in Stage 3 Type 1 Diabetes. People in the study will be treated with either Teplizumab or a placebo. A placebo looks like the drug but does not contain the medication. Being in the study requires up to 33 study visits over 78 weeks. Medical tests will be done during the study to track the health of participants.
- All genders
- All Ages
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 1 to 25 years old
- Newly diagnosed with Stage 3 Type 1 Diabetes and within 8 weeks of the Stage 3 T1D diagnosis
- Positive for at least one T1D autoantibody and a specific random C-peptide level at screening
- Childbearing age must use specific birth control
- Able to attend in-person visits at the study clinic
Exclusion Criteria
- Diagnosis of other diabetes except autoimmune T1D
- Active serious infection and/or fever within the 48 hours prior to the first dose of study drug
- Current diagnosis of human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- History or current diagnosis of tuberculosis (TB)
- Diagnosis of other autoimmune diseases, except clinically stable autoimmune thyroid disease, or controlled celiac disease
Will I be paid for my time?
Yes
IRB#: IRB_00189724
PI: Zoe Raleigh
Department: PEDIATRIC EDUCATION
Approval Date: 2026-05-06 06:00:00
Study Categories: Diabetes Studies
Specialties: Pediatric Endocrinology & Metabolism
I am Interested