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Study Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to
Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active
Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

Sponsor Name:

Biogen

Purpose of Study:

The TOPAZ studies are evaluating an investigational medication in SLE
patients who are taking SLE non-biologic therapy. The purpose of the studies are to evaluate
the safety and potential effectiveness of the study drug, litifilimab, compared with placebo in
participants with active SLE, who are receiving lupus standard of care therapy in reducing
disease activity.

What Do the Studies Involve?

• The TOPAZ studies will last about a year and a half and include around 20 visits to the study site and may include follow-up telephone calls
• The TOPAZ studies are being conducted in more than 25 countries, with about 180 clinical trial locations
• Approximately 1,080 patients with active SLE who will be staying on their current treatment for SLE will be involved in the studies
• Participants will continue their current SLE medication during the study with the potential to add the study medication being evaluated
• Participants will receive either active study medication or placebo (which looks like the study medication but contains no active medication)

Participants who complete the trial on study medication may be eligible for a long-term
extension study in which all participants receive the study drug, litifilimab, for up to 3 years.

To Consider Participation in These Studies, You Must Be*:

• 18 years of age or older
• diagnosed with SLE for at least 6 months
• currently taking medication to treat SLE
• currently experiencing disease-related symptoms

* The study team can discuss with you any additional criteria to participate. If you don’t initially
qualify, you may choose to be contacted at a later time to see if you may qualify in the future.

If you qualify and decide to take part, you will receive:

• All study-related care and study medication at no charge
• Regular monitoring of your SLE and overall health by physicians and/or research study staff who specialize in SLE
• Reimbursement for transportation and other expenses such as childcare and eldercare to attend study visits, as needed
• The opportunity to potentially improve the care for people with SLE

Study Type:

• Interventional (Clinical Trial) Phase III

Learn more and see if you may qualify here.

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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.