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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 451 people with SLE globally.

The study is currently enrolling patients.

See if you may be eligible - 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 to investigate the safety of the investigational medication and what effect it may have on disease activity of SLE, including its effects on the symptoms of SLE, such as tiredness, joint and muscle pain and skin rash. This global study will assess 3 doses of the investigational medication compared to placebo (a pill with no medication in it).

People who participate in the BTKi-SLE Study may be able to continue using certain medications and therapies that they use for SLE during the study. They will also take either the investigational medication or placebo (which looks the same as the investigational medication but contains no actual medication). The study team will review and discuss all medications with each study participant. See below for additional information regarding current medications.

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

  • Your participation will last for approximately 14 months and will require 20 visits to the study center.
  • Participants in the BTKi-SLE Study will be randomly assigned to placebo (a pill with no medication in it) or 1 of 3 investigational medication treatment groups.
  • Neither you nor your study doctor will know which group you have been assigned to.
  • You may be able to continue using certain medications and therapies that you use for your SLE during the study. This may depend on the type and dose of the medications that you are using. The study team will review your current medications and discuss all your medications with you.
  • 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 around a potential new treatment for SLE