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About the Investigational Medication

People with systemic lupus erythematosus (SLE) have an immune system that works against itself. Their immune systems produce antibodies which attack the body’s own building blocks (called proteins and cells). This reaction results in inflammation, which causes the symptoms of SLE and may lead to organ damage.

In the BTKi-SLE Study, the investigational medication is believed to block the action of a specific protein in the body called Bruton’s tyrosine kinase (BTK). BTK is involved in many immunological processes and researchers think BTK may be a factor which causes patients to develop SLE symptoms.

It is hoped that the investigational medication will limit the immune system’s attack on the body and reduce the inflammation that causes SLE symptoms and damage of organs and improve patients’ quality of life.

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).

The effect of the investigational medication on symptoms is not known. The investigational medication has already been given to a small number of healthy volunteers, and has been well tolerated in these individuals. It has not yet been approved by any healthcare authority for the treatment of patients with SLE.

Participation in this clinical research study does not guarantee that you will benefit from the investigational medication. All investigational medication will be provided to you free of charge.