The TOPAZ Study: Phase III Investigational Treatment for Systemic Lupus Erythematosus (SLE)

Clinical Trial Title

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

National Clinical Trial Number:


Contact Information

Ashleigh Machado

Clinical Trial Protocol Description:

In this study, you would have a 2:1 ratio of receiving the study medication to placebo. All participants will remain on their nonbiologic standard of care SLE therapy during the study. The study will last for 80 weeks and consist of 20 visits to our clinic and 2 follow up phone calls. 

All participants who complete this study will be eligible to participate in a long-term extension study, where all participants will receive the study treatment for up to 3 years.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are 18 years of age or older.
  • Have been diagnosed with SLE for at least 24 weeks.
  • Are receiving a current treatment for your SLE with either: 
    • antimalarials as stand-alone treatment
    • antimalarial treatment in combination with oral corticosteroids and/or a single immunosuppressant
  • Have no active lupus nephritis, active neuropsychiatric SLE, or comorbid autoimmune disease. 

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Meenakshi Jolly, MD

Contact Information

Ashleigh Machado

Clinical Trial Location

RUSH University Medical Center


RUSH University Medical Center

1620 W Harrison St
Chicago, IL 60612

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