VIBRANT: VIB4920 for Active Lupus Nephritis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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).

Key facts

Study ID

NCT05201469

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

74

Starts

2022-05-16

Expected to finish

2027-03-01

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals who meet all of the following criteria are eligible for enrollment as study participants:
• Age 18 years or older.
• Classification of Systemic Lupus Erythematosus (SLE) by any of the following criteria: the 1997 update of the 1982 American College of Rheumatology (ACR) criteria, the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, or the 2019 European League Against Rheumatism (EULAR)/ACR criteria.
• UPCR ≥ 1.0 based on a 24-hour urine collection at Visit -1 or within 14 days prior to Visit -1.
• Renal biopsy within 24 weeks prior to Visit -1 of ISN/RPS LN with both of the following:
• Class III, Class IV, or Class V in combination with Class III or IV, and
• Modified NIH Activity Index ≥ 1.

You may not qualify if…

• Individuals who meet any of these criteria are not eligible for enrollment as study participants:
• Inability or unwillingness to give written informed consent or comply with study protocol.
• Contraindication to treatment with MMF or mycophenolate sodium; or treatment with MMF or mycophenolate sodium is inappropriate in the opinion of the investigator.
• Treatment with a biologic agent, except belimumab, or investigational agent within 90 days or 5 half-lives prior to Visit 0, whichever is longer.
• Rituximab or other B cell depleting agent within 6 months prior to Visit 0.
• Prior treatment with VIB4920.
• Receipt of a live attenuated vaccine within 4 weeks prior to Visit 0.
• Comorbidities requiring treatment with systemic corticosteroids, including those that have required 3 or more courses of systemic corticosteroids within 12 months prior to Visit 0.
• Current malignancy or history of malignancy, except for adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ > 12 months prior to Visit 0.
• ESRD, defined as eGFR < 20 ml/min/1.73m2.
• History of transplantation.
• The following risks for thromboembolic events:
• Recent or recurrent deep venous thrombosis or arterial thromboembolism.
• Immobilization or major surgery within 12 weeks prior to Visit 0.
• History of congenital or inherited deficiency of antithrombin III, protein S, or protein C.
• History of anti-phospholipid syndrome, according to the 2006 Sapporo classification criteria.
• History of a severe allergy or hypersensitivity reaction to any component of the VIB4920 formulation.
• Any one of the following laboratory abnormalities:
• Peripheral B cell count < 5/μl.
• Neutropenia (absolute neutrophil count < 1000/mm3).
• Anemia (hemoglobin < 8 g/dL).
• Thrombocytopenia (platelets < 50,000/mm3).
• Aspartate aminiotransferase or alanine aminotransferase ≥ 2x upper limit of normal.
• Evidence of current or prior tuberculosis infection, including any of the following:
• Positive QuantiFERON-TB Gold or TB Gold Plus test.

Where it is running

• University of South Carolina — Charleston, South Carolina, United States (enrolling)
• UCLA Medical Center: Division of Rheumatology — Los Angeles, California, United States (enrolling)
• of California, Irvine School of Medicine Division of Rheumatology — Orange, California, United States (enrolling)
• University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center — San Francisco, California, United States (enrolling)
• University of Colorado School of Medicine: Division of Rheumatology — Aurora, Colorado, United States (enrolling)
• Yale University School of Medicine: Section of Rheumatology — New Haven, Connecticut, United States (enrolling)
• University of Miami Miller School of Medicine: Nephrology & Hypertension Division — Miami, Florida, United States (enrolling)
• Emory University School of Medicine: Division of Rheumatology — Atlanta, Georgia, United States (enrolling)
• University of Chicago, Department of Medicine: Rheumatology — Chicago, Illinois, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Washington University School of Medicine in St. Louis: Division of Nephrology — St Louis, Missouri, United States (enrolling)
• Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases — Manhasset, New York, United States (enrolling)
• University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology — La Jolla, California, United States (enrolling)
• Columbia University Medical Center: Department of Medicine, Division of Rheumatology — New York, New York, United States (enrolling)
• Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology — Hershey, Pennsylvania, United States (enrolling)
• Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology — Philadelphia, Pennsylvania, United States (enrolling)
• Hospital for Special Surgery, New York: Division of Rheumatology — New York, New York, United States

Full record on ClinicalTrials.gov

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