VIB4920 for Active Lupus Nephritis (VIBRANT)

Principal Investigator

Betty Diamond, MD | Feinstein Institute for Medical Research

David Wofsy, MD | University of California San Francisco School of Medicine

Maria Dall'Era, MD | University of California San Francisco School of Medicine

Locations

University of California Los Angeles | Los Angeles, CA

University of California San Diego | La Jolla, CA

University of California San Francisco | San Francisco, CA

Yale University | New Haven, CT

University of Miami | Miami, FL

Emory University | Atlanta, GA

University of Chicago | Chicago, IL

University of Minnesota | Minneapolis, MN

Washington University in St. Louis | St. Louis, MO

Columbia University | New York, NY

Hospital for Special Surgery | New York, NY

The Feinstein Institutes for Medical Research | Manhasset, NY

Temple University | Philadelphia, PA

Study Code

ITN091AI

Study Status

Active

Abstract

The goal of the VIBRANT trial is to determine if treating lupus nephritis with VIB4920 in addition to standard therapy is more effective than treating lupus nephritis with standard therapy alone.

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:

Receive VIB4920 or placebo via IV at Weeks 10, 12, 14, 18, 22, 26, 30, and 34. There will also be a study visit without an infusion at Week 11.
Continue to receive MMF and prednisone.
Have a kidney biopsy Week 38.
Have follow-up study visits at Weeks 48 and 60.

[Clinicaltrials.gov][Study Website]