About this study
The purpose of this study is to see if anti-CD3 (teplizumab) can stop or delay the immune process that causes type 1 diabetes. This is a phase 2 prevention trial through the National Institute’s of Health’s TrialNet.
What is anti-CD3 (teplizumab)
Anti-CD3 is a monoclonal antibody being studied to help treat and prevent type 1 diabetes (T1D). In T1D, a malfunction in the immune system targets beta cells for attack. Anti-CD3 interferes in the autoimmune attack. It helps the body police specific immune processes so that only real threats (infections) are targeted for immune destruction; not pancreatic beta cells. Read more about the immune system, anti-CD3 and type 1 diabetes.
To participate in the teplizumab study one must:
- Meet criteria for TrialNet blood test
- Between ages of 8-45
- Presence of at least 2 diabetes autoantibodies
- Abnormal Glucose Tolerance Test (OGTT)
One is not eligible to participate in the study if:
- T1D previously diagnosed or detected at screening
- Abnormalities in blood counts, liver enzymes, INR
- Positive PPD test
- Vaccination with live virus within 6 weeks of randomization
- Evidence of acute infection based on laboratory testing or clinical evidence
- Serological evidence of past or current HIV, hepatitis B, or Hepatitis C infection
- Currently pregnant or lactating
- Prior treatment with study drug
- Prior treatment with other monoclonal antibody in the past one year
What will I be asked to do if I participate in this study
Participating in the study involves getting an intravenous infusion of teplizumab or a placebo for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2-hour observation period.
There are six medical centers where the infusions take place, including at the University of Chicago Medicine. Your study staff will assist with providing lodging near one of the centers for two weeks so that you can make it to your infusion appointment each day. Lodging and travel is paid for by the study.
During the first year, you will need to come to a study center for follow-up visits and blood tests. After the first year, study follow-up visits will be every 6 months, and at other times as needed. There are numerous medical centers in 48 states at which the follow up visits take place. TrialNet covers the travel expenses. See a complete list of follow-up sites at TrialNet.
How to participate
If you have questions about the study or are interested in participating, please contact Gail at firstname.lastname@example.org.