Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05201469

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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