Finding new lupus treatment options can start with you

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.

If you’re not currently experiencing an SLE flare, you can still take the prescreener and sign up to receive reminder emails about this study.

OUTRACE SLE is a Phase 1 clinical study, meaning it is evaluating a study medicine to see if it is safe, and how well it is tolerated by people with SLE.

OUTRACE SLE 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 (up to 8 weeks): Up to 6 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 receiving a new dose of the study medication to monitor for side effects
• Follow-up Period (40 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

All study-related care, travel reimbursement, and the study medicine will be provided at no cost; health insurance is not required to participate.

Yes, your participation is completely voluntary. If you decide to participate in a clinical study, you are always free to withdraw at any time, for any reason, without penalty or effect on your future medical care.

No, your doctor doesn’t have to give you permission to participate. Feel free to talk to your doctor about participating in the study. With your permission, the study doctor will keep your regular doctor updated about your condition during the study.

The information you provide will not be shared with anyone who is not directly associated with this clinical study without your permission, except as required by law.

You could experience side effects associated with the study medicine and your symptoms may not improve or may get worse during the clinical study. The doctor or study team will discuss all the possible risks and potential benefits in detail with you.

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.

To help ensure that a clinical study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees review and approve study protocols.

Cullinan Therapeutics is sponsoring OUTRACE SLE.

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/)