VIBRANT: VIB4920 for Active Lupus Nephritis
Start Date
5/16/2022
Completion Date
3/1/2027
Summary
This is a multi-center double-blind placebo controlled clinical trial evaluating the efficacy of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in achieving a renal response in participants with active lupus nephritis (LN).
Detailed Description
Seventy-four eligible participants with active lupus nephritis (LN) will be randomized to receive VIB4920 1500 mg or placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will receive a total of 1000 mg of methylprednisolone according to either of the following schedules: * 1000 mg methylprednisolone IV at Day 0, or * 500 mg methylprednisolone IV at Day 0 and at Day 1. Participants who previously received 1000 mg of methylprednisolone IV within 42 days of Visit 0 will not receive additional methylprednisolone IV on Day 0. Participants who previously received less than 1000 mg of methylprednisolone IV within 42 days of Visit 0 will receive an additional dose of methylprednisolone IV at Day 0, according to the following formula, where X is the intravenous dose previously received and Y is the intravenous dose administered on Day 0: 1000 mg - X = Y. Participants will also receive MMF 2-3 g per day and will receive prednisone 25 mg/d beginning on Day 0, or on the day after completion of methylprednisolone. Prednisone will be tapered to 5 mg/d by Week 8.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
VIB4920
Placebo for VIB4920
Conditions
Locations
University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
La Jolla, California 92093
United States
UCLA Medical Center: Division of Rheumatology
Los Angeles, California 90095
United States
of California, Irvine School of Medicine Division of Rheumatology
Orange, California 92868
United States
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
San Francisco, California 94143
United States
University of Colorado School of Medicine: Division of Rheumatology
Aurora, Colorado 80045
United States
Yale University School of Medicine: Section of Rheumatology
New Haven, Connecticut 06519
United States
University of Miami Miller School of Medicine: Nephrology & Hypertension Division
Miami, Florida 33136
United States
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia 30307
United States
University of Chicago, Department of Medicine: Rheumatology
Chicago, Illinois 60637
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Washington University School of Medicine in St. Louis: Division of Nephrology
St Louis, Missouri 63110
United States
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Manhasset, New York 11030
United States
Hospital for Special Surgery, New York: Division of Rheumatology
New York, New York 10021
United States
Columbia University Medical Center: Department of Medicine, Division of Rheumatology
New York, New York 10032
United States
Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology
Hershey, Pennsylvania 17033
United States
Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology
Philadelphia, Pennsylvania 19140
United States
University of South Carolina
Charleston, South Carolina 29425
United States