AG019 & Teplizumab Study
Study Name: Testing AG019 and Teplizumab in Newly Diagnosed Type 1 Diabetes Patients
Principal Investigator: Carla Greenbaum, MD
What is the AG019 and Teplizumab Study?
We are recruiting newly diagnosed individuals for this multi-center study, sponsored by Intrexon T1D Partners, that investigates the safety and tolerability of two different doses of AG019 when given alone or in combination with teplizumab. AG019 is a new drug that may interrupt the autoimmune attack on insulin-producing cells in the pancreas during type 1 diabetes. The drug teplizumab (Anti-CD3) has shown value in earlier studies in preserving insulin-producing cells.
AG019 consists of living lactic acid bacteria (which are also present in some dairy products) which have been modified to produce specific proteins when released in the small intestine. Participants take the treatment orally, with twice-daily capsules for eight weeks.
Teplizumab is a drug that can alter the immune system attack on insulin-producing cells. In addition to eight weeks of AG019 capsules by mouth, some participants will receive daily IV infusions of teplizumab for the first 12 days.
Who can participate?
You may be eligible to participate if you:
- have been diagnosed with type 1 diabetes within 150 days,
- are 12 - 40 years of age,
- test positive for at least one diabetes-related autoantibody,
- are in good general health.
Participants must wear a continuous glucose monitor (CGM) provided by the sponsor during the study.
What will study participants be asked to do?
First, a researcher will have a phone conversation with you to review initial screening criteria. If you meet initial criteria, you’ll be invited to Benaroya Research Institute’s clinical research center at Virginia Mason Hospital for a five-hour visit that determines eligibility to participate. If you are found to be eligible to participate, you will be assigned to either Part 1 or Part 2 of the study.
- Part 1: AG019 capsules by mouth, twice-daily for eight weeks. Six clinic visits during this eight-week treatment phase.
- Part 2: AG019 capsules by mouth, twice daily for eight weeks, plus daily IV infusion of teplizumab (or placebo) for the first 12 days. Fourteen clinic visits during the eight-week treatment phase.
After the eight-week treatment phase, follow-up visits are every three months, out to one year.
Participation in the study is one year. Study visits may include:
- collection of medical history
- physical exam
- blood tests
- mixed meal tolerance test
- stool sample collection
All visits take place in Seattle. If you’d like to participate, please call us at 800-888-4187 or email firstname.lastname@example.org.