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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.

The investigational medication being evaluated in the BTKi-SLE Study is believed to block the action of a specific protein in the body called Bruton’s tyrosine kinase (BTK). Stopping the action of BTK is thought to block some of the processes in the immune system that are responsible for causing the symptoms of SLE.

The study is investigating whether this investigational medication may reduce the inflammation that causes SLE symptoms and damage of organs.

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.

The effect of the investigational medication on SLE symptoms is not known. The investigational medication has already been given to a small number of healthy volunteers, and some of the healthy volunteers reported headaches, runny noses, fatigue and respiratory tract infections. It has not yet been proven safe and effective, and has not been approved by any healthcare authority. There is no guarantee that it will be approved 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.