VIBRANT: VIB4920 for Active Lupus Nephritis

NCT05201469 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DAIT ITN091AI
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 17

Brief 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).

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis; Mycophenolate mofetil; VIB4920

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving a complete renal response at week 36

  Complete renal response is defined as all of the following: 1. Urine protein-to-creatinine ratio (UPCR) \<= 0.5, based on a 24-hour urine collection 2. Estimated glomerular filtration rate (eGFR) \>= 120 ml/min/1.73 m\^2 or, if \< 120 ml/min/1.73 m\^2, then \>= 80 percent of the eGFR at baseline 3. Prednisone \<= 5 mg/day from Week 8, according to the prednisone dosing restrictions

  Week 36

Secondary Outcomes (14)

• Proportion of participants who achieve a complete renal response

  Weeks 12, 24, 48, and 60

• Proportion of participants who achieve an overall renal response

  Weeks 12, 24, 36, 48 and 60

• Proportion of participants who achieve a BLISS-LN primary efficacy renal response (PERR)

  Weeks 12, 24, 36, 48, and 60

• Urine Protein-to-Creatinine Ratio (UPCR)

  Weeks 12, 24, 36, 48, and 60

• Anti-dsDNA antibodies

  Weeks 12, 24, 36, 48, and 60

Study Arms (2)

VIB4920

EXPERIMENTAL

Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. 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 begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to 5 mg per day by Week 8. The prednisone dose may be tapered more rapidly and to a dose lower than 5 mg/d, at the discretion of the site investigator. Prednisone of no more than 5 mg/d will be continued until Week 60.

Drug: VIB4920

VIB4920 Placebo

PLACEBO COMPARATOR

Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. 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 begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to 5 mg per day by Week 8. The prednisone dose may be tapered more rapidly and to a dose lower than 5 mg/d, at the discretion of the site investigator. Prednisone of no more than 5 mg/d will be continued until Week 60.

Drug: Placebo for VIB4920

Interventions

VIB4920 DRUG

Participants will receive 1500 mg of VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone

VIB4920

Placebo for VIB4920 DRUG

Participants will receive placebo for VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone

VIB4920 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (17)

University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology

La Jolla, California, 92093, United States

RECRUITING

UCLA Medical Center: Division of Rheumatology

Los Angeles, California, 90095, United States

RECRUITING

of California, Irvine School of Medicine Division of Rheumatology

Orange, California, 92868, United States

RECRUITING

University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

San Francisco, California, 94143, United States

RECRUITING

University of Colorado School of Medicine: Division of Rheumatology

Aurora, Colorado, 80045, United States

RECRUITING

Yale University School of Medicine: Section of Rheumatology

New Haven, Connecticut, 06519, United States

RECRUITING

University of Miami Miller School of Medicine: Nephrology & Hypertension Division

Miami, Florida, 33136, United States

RECRUITING

Emory University School of Medicine: Division of Rheumatology

Atlanta, Georgia, 30307, United States

RECRUITING

University of Chicago, Department of Medicine: Rheumatology

Chicago, Illinois, 60637, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University School of Medicine in St. Louis: Division of Nephrology

St Louis, Missouri, 63110, United States

RECRUITING

Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases

Manhasset, New York, 11030, United States

RECRUITING

Hospital for Special Surgery, New York: Division of Rheumatology

New York, New York, 10021, United States

NOT YET RECRUITING

Columbia University Medical Center: Department of Medicine, Division of Rheumatology

New York, New York, 10032, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology

Hershey, Pennsylvania, 17033, United States

RECRUITING

Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Links

• Immune Tolerance Network (ITN)
• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria Dall'Era, M.D.

  University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

  STUDY CHAIR

• Betty Diamond, M.D.

  Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases

  STUDY CHAIR

• David Wofsy, M.D.

  University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: May 16, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 24 months after database lock for the trial
• Access Criteria: Open Access

Locations

US (17)