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About the BTKi-SLE Clinical Research Study

The BTKi-SLE Study is a global clinical research study looking at an investigational medication for people with SLE.

The study will enroll about 432 people with SLE at approximately 168 study centers in 18 countries around the world.

See if you may pre-qualify - take the pre-screener questionnaire

Systemic lupus erythematosus, commonly referred to as lupus or SLE, is an autoimmune disease. This means that the immune system (which normally protects the body from infections) mistakenly attacks healthy cells. People with lupus may have symptoms in and damage to the affected parts of the body, such as the skin, joints, kidneys, brain and other organs.

By participating in the BTKi-SLE Study, you will help researchers better understand the safety of the investigational medication and how well it works, including its effects on the symptoms of SLE, such as tiredness, joint and muscle pain and skin rash. Researchers will also determine which dose is most effective at reducing SLE symptoms.

The investigational medication works differently than other standard medicines used to treat SLE. People who participate in the BTKi-SLE Study will continue taking their current SLE medications and will also take either the investigational medication or placebo (which looks the same as the investigational medication but contains no actual medication).

What to Expect If You Take Part in the BTKi-SLE Study:

  • Your participation will last for approximately 60 weeks (just over 1 year) and will require 18 visits to the study center.
  • Participants in the BTKi-SLE Study will be randomly assigned to 1 of 4 investigational medication treatment groups.
  • Three of the treatment groups will receive the investigational medication.
  • One treatment group will receive placebo (an inactive medication).
  • Neither you nor your study doctor will know which group you have been assigned to.
  • You will receive your current (standard-of-care) treatment even if you are not receiving the investigational medication (i.e., if you are in the placebo group).
  • During your visits, the study doctor and staff will monitor your health and progress by conducting blood, urine and other lab tests and assessments.
  • All study-related treatments, procedures and assessments are conducted at no cost to you.

It’s your choice

You may choose to stop participating in this clinical research study at any time, for any reason. The study doctor and staff are available to discuss any concerns or questions you may have before you decide to participate.

Learn more about the investigational medication

Why you may want to participate:

Close care and monitoring by a study doctor and staff throughout the study
No cost for study treatment and medication, related tests, procedures and assessments
The opportunity to play a role in advancing the understanding of treatment for SLE