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Sponsor Name:

Bristol Myers Squibb

Purpose of Study

The purpose of this clinical trial is to determine whether the investigational drug, afimetoran, is safe and effective in treating patients with active systemic lupus erythematosus with symptoms compared with placebo. A placebo is a substance that looks like the study medication but contains no active ingredients. The study also hopes to determine if there is one dose that works better than another.

What Does this Study Involve? 

•  The study will include about 268 participants and last for about 56 weeks (just over one year). There will also be an optional extension period where you may continue to receive study treatment with afimetoran for an additional year.
• The first 5 weeks of the study is the screening period. This is when the study staff will review your medical records to see if you are eligible to enroll in the study. 
• The next 48 weeks is called the placebo-controlled study period. Participants will be randomized (assigned by chance) to one of four treatment groups. This means patients will be equally divided among each of the four groups. Three of the groups will receive the investigational drug, afimetoran and the fourth group will receive a placebo (a pill with no active medication).  
• The last 4 weeks of the study is for follow-up during which time you will stop the study medication but will continue to be monitored.
• During the study, participants will be allowed to take standard of care therapy at the right dose, like corticosteroids, as managed by the study doctor.
  bel extension period is available after completion of the study treatment period.  

You may participate in the study if you are:

• Are 18 to 70 years old. 
• Have been diagnosed with active SLE with symptoms.
• Are currently being treated for your lupus.

If you have any of the following, you will not be able to participate in the study: 

• Are pregnant, lactating, breastfeeding, or planning pregnancy during the study period. 
• Kidney disease (lupus nephritis) that is active and severe as evaluated by the investigator

There are additional eligibility criteria, which a study doctor will explain to you.  

You may be reimbursed for your time and travel expenses incurred while visiting the site for study visits.  

Study Type:

• Interventional
• Phase 2
• In multiple study centers around the country

Learn More

Before you choose to participate, you should speak with your doctor.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.