Actively Recruiting
VIBRANT: VIB4920 for Active Lupus Nephritis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-12-19
74
Participants Needed
17
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
VIBRANT: VIB4920 for Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of systemic lupus erythematosus (SLE) by ACR 1997, SLICC 2012, or EULAR/ACR 2019 criteria
- Urine protein to creatinine ratio (UPCR) of 1.0 or higher from a 24-hour urine collection near study start
- Kidney biopsy within 24 weeks before screening showing Class III, IV, or V lupus nephritis with modified NIH Activity Index of 1 or greater
You will not qualify if you...
- Unable or unwilling to provide informed consent or follow study procedures
- Contraindication or inappropriate treatment with mycophenolate mofetil or mycophenolate sodium
- Use of biologic or investigational agents (except belimumab) within 90 days before starting study
- Use of rituximab or other B cell depleting agents within 6 months before starting study
- Previous treatment with VIB4920
- Receipt of live attenuated vaccine within 4 weeks before starting study
- Need for systemic corticosteroids for other conditions, or 3 or more courses of corticosteroids within past year
- Current or past malignancy except treated basal cell, squamous cell, or cervical carcinoma in situ over 12 months ago
- End-stage renal disease with eGFR below 20 ml/min/1.73m2
- History of transplantation
- Recent or recurrent blood clots, major surgery or immobilization within 12 weeks, or inherited clotting disorders
- History of anti-phospholipid syndrome
- Severe allergy to any component of VIB4920
- Low peripheral B cell count, neutropenia, anemia, thrombocytopenia, or elevated liver enzymes
- Current or prior tuberculosis infection based on tests
- HIV infection
- Current or past hepatitis B or C infection, except treated hepatitis C
- Active infections
- History of significant or recurrent infections posing risk
- Severe psychiatric conditions interfering with study compliance
- Current or recent substance abuse
- Lack of peripheral venous access
- Pregnancy or breastfeeding
- Unwillingness to use contraception if applicable
- Other medical problems or findings that could pose risks or interfere with study participation or data quality as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
La Jolla, California, United States, 92093
Actively Recruiting
2
UCLA Medical Center: Division of Rheumatology
Los Angeles, California, United States, 90095
Actively Recruiting
3
of California, Irvine School of Medicine Division of Rheumatology
Orange, California, United States, 92868
Actively Recruiting
4
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
San Francisco, California, United States, 94143
Actively Recruiting
5
University of Colorado School of Medicine: Division of Rheumatology
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Yale University School of Medicine: Section of Rheumatology
New Haven, Connecticut, United States, 06519
Actively Recruiting
7
University of Miami Miller School of Medicine: Nephrology & Hypertension Division
Miami, Florida, United States, 33136
Actively Recruiting
8
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States, 30307
Actively Recruiting
9
University of Chicago, Department of Medicine: Rheumatology
Chicago, Illinois, United States, 60637
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Washington University School of Medicine in St. Louis: Division of Nephrology
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Manhasset, New York, United States, 11030
Actively Recruiting
13
Hospital for Special Surgery, New York: Division of Rheumatology
New York, New York, United States, 10021
Not Yet Recruiting
14
Columbia University Medical Center: Department of Medicine, Division of Rheumatology
New York, New York, United States, 10032
Actively Recruiting
15
Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
16
Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
17
University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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