SELECT-SLE
Study Title:
A Phase 3 study evaluating an investigational drug in patients living with lupus (SLE, Systemic Lupus Erythematosus)
Sponsor name:
AbbVie
Purpose of Study:
The SELECT-SLE Research Study is a clinical research study designed to evaluate the safety and efficacy of the investigational drug compared to placebo in reducing disease activity/flares and improving the quality of life for participants living with lupus (SLE, Systemic Lupus Erythematosus). Participants receive either the investigational drug or a placebo (something that looks like the investigational drug, but has no effect on the body). Both the investigational drug and placebo will be administered as oral treatments on top of other lupus treatments participants are already receiving.
What does this study involve?
- The study will include approximately 1,000 participants and will consist of approximately 21 visits over 112 weeks (just over 2 years).
- The first 6 weeks of the study is the screening period when the study staff will review your medical records and lab results and evaluate your lupus symptoms to see if you are eligible to enroll in the study.
- The next 52 weeks will be the placebo-controlled study treatment period. Participants will be randomized (assigned by chance) to one of two groups. This means participants will be equally divided among each of the groups. One group will receive the investigational drug and the other group will receive a placebo (a pill with no active drug).
- The next 52 weeks will be the long-term extension period. All participants will receive the investigational drug during this time.
- The last 4 weeks of the study will be the follow-up period. Participants will have stopped taking the investigational drug but will continue to be monitored.
- Participants who complete both periods of the study may have the option to continue to take the investigational drug if participants and their study doctor think they can continue to benefit from it, in accordance with local regulations.
- During the study, all participants will be maintained on standard of care therapy like corticosteroids, and/or antimalarials and/or immunosuppressants as managed by their study doctor.
You may participate in the study if you are:
- Are 18 to 63 years of age.
- Were diagnosed with systemic lupus erythematosus at least 6 months ago.
- Feel lupus symptoms despite treatment with an oral corticosteroid, and/or an antimalarial, and/or an immunosuppressant.
If you have any of the following, you will not be able to participate in the study:
- Lupus nephritis (kidney disease from lupus) that was treated with induction therapy within the past 6 months.
- Are currently receiving hemodialysis (or other forms of renal replacement therapy).
Study Type:
- Interventional (Clinical Trial)
- Phase III
The investigational drug, the study-related laboratory tests, examinations, and clinic visits performed as part of this study will be provided at no charge to you. You may be reimbursed for your travel expenses incurred while visiting the site for study visits.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.