Research exploring a potential new treatment for systemic lupus erythematosus (SLE)
Study Title: The BTKi-SLE study
Sponsor: EMD Serono, a subsidiary of Merck KGaA
Purpose: The BTKi-SLE study is looking at the safety and efficacy of an investigational medication called M2951 in people with active systemic lupus erythematosus (SLE), a type of lupus. The study will also look at which dose works best to reduce the symptoms of SLE, and how the investigational medication affects participants’ quality of life.
Study Type: Investigational Drug Trial
What does the BTKi-SLE study involve?
The study will enroll about 432 people with SLE at approximately 168 study centers in 18 countries around the world. Participation in the study will last for approximately one year and two months. The study is divided into three parts: screening (up to four weeks), treatment (one year) and follow-up (about four weeks).
During the screening period, you will visit the study center once, where the study doctor will perform several tests to assess whether you are eligible to participate in the study.
If you meet all of the study requirements, you will be randomly assigned to one of four investigational medication treatment groups. Three of the treatment groups will be given the investigational medication (M2951). Each group will receive a different dose. One treatment group will receive an inactive medication also known as placebo. As part of the study, you will continue to receive your current (standard-of-care) treatment, regardless of what treatment group you are assigned to.
During the treatment period, you will take the study medication every day. You will visit the study center approximately 16 times in total — four times during the first month, then once every four weeks. At each study visit, the study doctor will do several assessments to monitor your health.
You will attend one follow-up visit four weeks after the last dose of study medication.
There is no cost for study-related treatments, procedures or assessments. You do not need to have medical insurance to participate.
To take part in this study, you must:
- be 18 to 75 years old
- have a diagnosis of SLE for at least six months
If you have any of the following conditions, you may not be able to participate in the study:
- Are pregnant or breast-feeding
- Severe or progressive central nervous system SLE
- Autoimmune conditions: celiac disease, inflammatory bowel disease, Graves’ disease, asthma
- A demyelinating disorder, such as multiple sclerosis, that affects the nervous system
- Active or latent tuberculosis (TB) infection
To find out more about the BTKi-SLE study and take a short questionnaire to see if you are eligible to participate, please visit LupusStudy.com or call 877-888-9764.
The Lupus Foundation of America works to educate and inform about clinical trial study options available to people with lupus and the importance of getting involved to help advance lupus research. The Lupus Foundation of America does not endorse specific trials.