The EMBODY program is a global clinical research program testing the safety and effectiveness of an investigational study drug called epratuzumab in people with moderate to severe lupus.
As part of the EMBODY program, two clinical research studies are being conducted at over 300 participating study sites in approximately 30 countries worldwide. Approximately 780 people are expected to participate in each study. Click here to see if there is a participating site in your area.
Do I qualify to participate in the EMBODY program?
To qualify for the EMBODY program, you must meet the following criteria:
- At least 18 years of age
- Diagnosed with systemic lupus erythematosus
- Not pregnant or nursing
There are other criteria that you must meet to qualify for participation. The study doctor will decide if you are a good candidate for this clinical research program.
If you would like to participate in the EMBODY program, please click here to contact one of our participating study sites for more information.
What does study participation involve?
If you agree to participate and meet the study criteria, your participation in the EMBODY program will last approximately one year. You will be asked to attend up to 27 visits at a local study site during this time.
You will complete up to four 12-week study treatment cycles with the investigational study drug (epratuzumab) or an inactive placebo. The investigational study drug is given as an infusion once a week. Each study treatment cycle includes one weekly intravenous infusion for the first four weeks followed by eight weeks with no treatment. You may also be allowed to continue taking your current lupus treatments such as prednisone, other corticosteroids, or immunosuppressants for the duration of your participation.
At the conclusion of your participation, you may be able to participate in an open-label extension study where everyone will receive epratuzumab. The study doctor will decide if you qualify to participate in the extension study.
Throughout your participation, the study doctor will be monitoring your lupus symptoms and your general health. The investigational study drug, lab tests, and study-related procedures will be provided for all study participants.
Participation in the EMBODY program is completely voluntary. You do not have to participate in the EMBODY program to receive treatment for your lupus. The study doctor will explain any other treatments that may be available.
What is the investigational study drug?
The investigational study drug being tested is called epratuzumab. Epratuzumab targets specific cells that are part of the immune system. This may prevent the immune system from attacking healthy tissue and help to reduce the level of inflammation in people with lupus.
Study participants will be randomly assigned (like drawing straws) to one of three study treatment groups during the treatment period. Two of the study treatment groups will receive epratuzumab and one will receive placebo. A placebo is a substance that looks like the investigational study drug but has no active ingredient. You have a 2 out of 3 or 67% chance of receiving epratuzumab. Neither you nor your study doctor will know to which treatment group you are assigned.
Why should I take part in the EMBODY program?
Your lupus symptoms may improve during your participation in this clinical research program. It is also possible that your lupus symptoms may not improve or may get worse.
Although you may not experience any direct health benefit, the information collected by the research team during your participation will help us to determine if epratuzumab can help other people with lupus in the future.
For More Information
If you would like to learn more about the EMBODY program, you can contact one of our participating sites for more information. Please click here to see if there is a participating site in your area.
Not a resident? Please visit the website for your country