Abatacept - Closed to Enrollment - Study Ongoing

Abatacept Prevention Study

We are testing the drug abatacept (CTLA-4Ig) to see if it can delay or prevent early T1D (stage 1) from progressing to stage 2 and ultimately prevent clinical diagnosis (stage 3). In earlier studies with individuals newly diagnosed (stage 3), those who took abatacept had improved insulin production and delayed insulin loss.

Participants in Stage 1
Prevention Study
Currently Not Enrolling

Stages of T1D

Type 1 Diabetes: Stage 1

Info graphic showing the stages of Type 1 Diabetes, and how stage 1 fits in the picture.

In stage 1, the immune system has started attacking insulin-producing beta cells. However, blood sugar levels remain normal and there are no symptoms.

About the Study

Study Details

Abatacept affects the auto-immune response that can result in progression of T1D. Known by the brand name Orencia®, abatacept is approved by the U.S. Food & Drug Administration (FDA) for use in several autoimmune diseases in adults and children as young as 6. Abatacept is also being studied for treatment of five other autoimmune diseases (Crohn’s, Multiple Sclerosis, Lupus, Arthritis and Psoriasis). 

In an earlier TrialNet study for people newly diagnosed, those who took abatacept showed 59% higher insulin production and prolonged insulin production. Improved insulin production helps prevent complications and improve disease management, including better control of blood sugar levels.  

Based on these promising results, we are now testing abatacept in people in stage 1 T1D. Our goal is to prevent further progression and T1D diagnosis (stage 3). 

As with any medical intervention, there are risks and benefits to participating in this study. Before you decide to participate, a member of our research team will explain all potential risks and benefits and answer any questions you may have. 

Eligibility Requirements

Who can participate?

To find out if this study is right for you, the first step is to sign up for Pathway to Prevention screening. To participate in this study, you need to:

  • be between the ages of 6 and 45 
  • have two or more diabetes-related autoantibodies, excluding MIAA autoantibody (determined by screening)
  • have normal results on an oral glucose tolerance test (OGTT)
  • NOT have had a “live” vaccine in the past 3 months
  • NOT be pregnant or planning to be pregnant
  • meet any other study requirements

Participant Experience

What is required?

The Abatacept Prevention Study has two phases: treatment and follow up. 

In the treatment phase, participants make three visits to a TrialNet site in the first four weeks (every other week); then one study visit a month for 11 months. Each visit takes about 2 hours and includes a 30-minute infusion, followed by one hour of observation.

In the follow up phase, participants return for tests and monitoring two times a year. Visits last about 2.5 hours. 

Half the people in the study will get the study drug; the other half will get a placebo (looks like the study drug but is inactive). A computer randomly selects who gets the study drug, and no one knows who is in which group until the end of the study. 

Regardless of which group you are in, you play an important role in advancing T1D research for the immediate study and well into the future. Once the study is over, blood samples from participants in the placebo arm of the study are used in other studies looking to answer questions about how T1D progresses and how to stop it. 

All study participants receive close monitoring. If you develop T1D, our tests will likely show this before you have any symptoms. For people taking part in T1D research, the risk of diabetic ketoacidosis (DKA) at diagnosis drops from 30% to less than 4%. DKA is a serious condition that can be life-threatening. With early notification, you will be able to see your doctor and start taking insulin before you feel sick.

If there aren’t any studies for newly diagnosed T1D that are right for you, we will invite you to take part in monitoring.