Finding new lupus treatment options can start with you

Learn more about a clinical study for people with systemic lupus erythematosus (SLE)

The OUTRACE SLE Study

About the Study

The OUTRACE SLE Study is a Phase 1 study. This means we’re evaluating a new investigational medicine to see if it’s safe and well tolerated in people living with SLE, and to gain further understanding of its effects in the body.

The OUTRACE SLE Study lasts up to one year, with an optional 48-week follow-up period. There are at least 13 study site visits. The study medicine is a type of medicine called a T cell engager, and is given up to four times, once a week, as an injection.

Who May Participate?

You may be able to participate in this clinical study if you*:

Are between 18 and 70 years old
Have been diagnosed with SLE
Have symptoms of SLE despite having tried other treatments

*There are additional criteria to check if this trial is a good fit for you. The study doctor will be able to talk with you about these criteria in more detail.

Why Participate?

You will be closely monitored by a dedicated team during monthly study visits for about a year
All study-related care, travel reimbursement, and study medicine will be provided at no cost; health insurance is not required to participate
You will have the opportunity to help researchers learn more about lupus

If you need support or travel assistance to participate in this study, please contact the study team.

About The Study Medicine

The study is testing a type of medicine called a T cell engager. It works by helping the body’s immune system to eliminate cells that cause SLE.

T cell engagers have been used in patients for many years and more recently studied in people living with autoimmune diseases including SLE.

Side effects seen with T cell engagers include increased risk of infection, fever, low blood pressure, and rapid heart rate. The study team can share more information on potential side effects and the treatments for them. Your safety is our highest priority.

All participants in the trial will receive the study medicine; there is no placebo in this clinical study (a placebo looks like the study medicine but contains no active ingredient). The study medicine will be given as an injection under the skin, called a subcutaneous injection.

Clinical studies help doctors explore whether a potential new medicine is safe and whether it works. Before a medicine can be prescribed for a condition, it must go through several phases of research. Clinical studies are performed according to government regulations that help protect the safety and rights of participants.

A study medicine is a drug that is not approved for use by doctors for the condition being studied. Study medicines are tested during clinical studies to see if they are safe and effective for a specific medical condition and/or group of people. Study medicines are not approved by a health authority for use, as the safety and effectiveness have not been established.

The OUTRACE SLE Study includes a Screening Period, Treatment Period, a Follow-up Period, and an Optional Observation Period.

Screening Period (up to 4 weeks): One study site visit for assessments, such as blood sample collection and a physical exam, to confirm if you are eligible to participate in the study
Treatment Period (4 weeks): Up to 4 weekly injections of the study medicine under the skin (subcutaneous). You will need to be monitored for 2 days in an inpatient setting like a hospital after at least the first 2 injections
Follow-up Period (44 weeks): Follow-up visits to monitor your health. Some visits will include assessments like a physical exam and blood sample collections
Optional Observation Period (48 weeks): This additional follow-up period is for interested participants and includes 4 visits in total

To help you decide whether to participate, the study team will explain the details of the study. They will give you an Informed Consent Form (ICF) that includes information about the study, such as its purpose, length, required procedures, potential benefits, and risks of participation. You will have the opportunity to ask questions and decide if taking part is right for you. If you decide to join the study, you will need to give your permission by signing the ICF.

Patient advocacy groups offer information, support, and resources to those interested in learning more about clinical studies. Explore the groups below for more information:

1. Lupus Foundation of America (https://www.lupus.org/)

2. Lupus Research Alliance (https://www.lupusresearch.org/)

3. Looms for Lupus (https://looms4lupus.org/)