Maria Dall'era | University of California San Francisco | San Francisco, CA

Betty Diamond | The Feinstein Institute for Medical Research | Manhasset, NY

David Wofsy | University of California San Francisco | San Francisco, CA

Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases | Manhasset, NY

Columbia University Medical Center: Department of Medicine, Division of Rheumatology | New York, NY

University of California San Francisco School of Medicine: Division of Rheumatology | San Francisco, CA

Emory University School of Medicine: Division of Rheumatology | Atlanta, GA

Yale University School of Medicine: Section of Rheumatology | New Haven, CT

UCLA Medical Center: Division of Rheumatology | Los Angeles, CA

University of Miami Miller School of Medicine: Nephrology & Hypertension Division | Miami, FL

University of Chicago, Department of Medicine: Rheumatology | Chicago, IL

Washington University School of Medicine in St. Louis: Division of Nephrology | St Louis, MO

University of Colorado Anschutz Medical Campus: Division of Renal Diseases and Hypertension | Aurora, CO

Medical University of South Carolina: MUSC Lupus Erythematous (M.U.S.C.L.E.) Research Group | Charleston, SC

About the Investigational Study Drug

VIB4920 is a bioengineered protein that works by blocking CD40L and preventing immune cells from attacking one’s own body, including the kidneys. VIB4920 was found to be safe, tolerable, and effective in an early phase trial in rheumatoid arthritis patients, and it is currently being used in other trials. VIB4920 is considered an experimental treatment because it has not been approved for use in lupus nephritis or other diseases.

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Participating in VIBRANT

Eligible participants will:

• Receive standard IV methylprednisolone and oral mycophenolate mofetil (MMF) therapy for LN.

• Take prednisone and rapidly decrease the dose during the first 8 weeks of the study.

• Have study visits at Weeks 4 and 8. At Week 8, participants will be evaluated to see how well they are responding to treatment. Participants who have responded well to treatment will leave the study and return to their rheumatologist or nephrologist for ongoing treatment. Participants who have not responded well will be assigned to treatment with either VIB4920 (2/3 of participants) or placebo (1/3 of participants).

• Participants assigned to treatment with VIB4920 or placebo will:

You may be eligible to participate in the VIBRANT Study if you:

• Are 18 years or older
• Have been diagnosed with Systemic Lupus Erythematosus
• Have active LN based on:
  • The amount of protein in your urine, and
  • The results of your kidney biopsy within 24 weeks before or at the screening visit.