The SunStone Study

What is the SunStone Study?

The SunStone Study is a type of research study called a clinical trial. The purpose of this study is to learn if a new investigational study drug called obexelimab can safely help treat adults with lupus.

ALREADY ENROLLED?

Two interlocking letter Os, The SunStone Study, adults 18 to 70 years old with systemic lupus erythematosus.

Who can participate?

The study is open to adults with lupus.

Age

18 to 70 years of age

Medicines

Taking an oral corticosteroid, antimalarial, and/or immunosuppressant for lupus

Diagnosis

Systemic lupus erythematosus

Also...

There are other requirements. The study doctor will discuss them with you.

What happens
during the study?

Your participation in this study, including the Screening Visit and Follow-up Visit, will be approximately 40 weeks (10 months).

There will be at least 12 scheduled visits at the study clinic.

TESTS AND HEALTH CHECKS IN THIS STUDY

Screening

You will have health checks and tests to see if you qualify for the study. If you do, you will start the study drug within 4 weeks of your Screening Visit.

Study
Treatment
Period

You will be assigned by chance to receive obexelimab or a placebo. You will come to the study clinic every 2 weeks for your first 2 visits and then you will return every 4 weeks (about once a month).*

Follow-up Period

There will be 3 monthly Follow-up Visits after your Week 24 visit.

*You may be contacted between monthly visits (if you are injecting at home) or come to the study clinic for weekly injections (if you are not injecting at home).

What kind of tests and health checks can I expect?

During the study, you will have tests and procedures performed to check your health, gather data on the effects of the study drug, and to see if you are able to continue taking the study drug. You will not have every test at each visit.