The SOAR study is being conducted to see if the study medication is safe and effective in treating patients with systemic lupus erythematosus (SLE). Specifically, the study is looking at whether the study medication, combined with your existing SLE treatment, may better control your SLE symptoms. To qualify for the study, you must still be experiencing SLE symptoms while on your current SLE medication(s).
If you qualify and you agree to participate, you may be in the study for up to 32 weeks. While in the study, you will continue to take the medicines you are currently taking for your SLE.
During the study, all participants will be given the study drug every other day for the first four weeks, and then two times per week for the remainder of the study. Eligible participants will receive the first dose of the study drug at the clinic. All other doses will be given at home by yourself or your caregiver.
Participants will receive either the investigational medication or a placebo, which looks like the study drug but has no active ingredient. Again, patients participating in this study will continue to take their existing SLE medications.
All participants will be monitored throughout the study, and a team will be on hand to answer all questions related to the study. If you qualify and agree to participate, you will receive the study medication and study-related care at no cost.
The study drug is a prescription drug approved in the U.S. by the Food and Drug Administration (FDA) for several different diseases, including use during a worsening or an increase in severity of SLE symptoms. It is a gel given by injection (a shot) under your skin. It has not been approved for use by patients in any country except the U.S. The SOAR study is being conducted to collect additional data regarding the study drug’s safety and effectiveness in reducing SLE symptoms.