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New hope for lupus nephritis: experimental drug VIB4920 enters Mid-Stage trial

NCT ID NCT05201469

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests an experimental drug called VIB4920 in people with active lupus nephritis, a serious kidney complication of lupus. About 74 adults will receive either VIB4920 or a placebo, along with standard medications, to see if the drug helps improve kidney function. The goal is to find a better way to control the disease and reduce kidney damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VIB4920 (an experimental drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for lupus nephritis, potentially helping more people achieve kidney remission.
What could go wrong
This is an early phase 2 trial with only 74 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older. 2. 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. 3. UPCR ≥ 1.0 based on a 24-hour urine collection at Visit -1 or within 14 days prior to Visit -1. 4. Renal biopsy within 24 weeks prior to Visit -1 of ISN/RPS LN with both of the following: 1. Class III, Class IV, or Class V in combination with Class III or IV, and 2. Modified NIH Activity Index ≥ 1. Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrollment as study participants: 1. Inability or unwillingness to give written informed consent or comply with study protocol. 2. Contraindication to treatment with MMF or mycophenolate sodium; or treatment with MMF or mycophenolate sodium is inappropriate in the opinion of the investigator. 3. Treatment with a biologic agent, except belimumab, or investigational agent within 90 days or 5 half-lives prior to Visit 0, whichever is longer. 4. Rituximab or other B cell depleting agent within 6 months prior to Visit 0. 5. Prior treatment with VIB4920. 6. Receipt of a live attenuated vaccine within 4 weeks prior to Visit 0. 7. 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. 8. 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. 9. ESRD, defined as eGFR \< 20 ml/min/1.73m2. 10. History of transplantation. 11. The following risks for thromboembolic events: 1. Recent or recurrent deep venous thrombosis or arterial thromboembolism. 2. Immobilization or major surgery within 12 weeks prior to Visit 0. 3. History of congenital or inherited deficiency of antithrombin III, protein S, or protein C. 4. History of anti-phospholipid syndrome, according to the 2006 Sapporo classification criteria. 12. History of a severe allergy or hypersensitivity reaction to any component of the VIB4920 formulation. 13. Any one of the following laboratory abnormalities: 1. Peripheral B cell count \< 5/μl. 2. Neutropenia (absolute neutrophil count \< 1000/mm3). 3. Anemia (hemoglobin \< 8 g/dL). 4. Thrombocytopenia (platelets \< 50,000/mm3). 5. Aspartate aminiotransferase or alanine aminotransferase ≥ 2x upper limit of normal. 14. Evidence of current or prior tuberculosis infection, including any of the following: 1. Positive QuantiFERON-TB Gold or TB Gold Plus test. 2. Positive T-SPOT.TB test. 3. Positive purified protein derivation (PPD) tuberculin test, defined as \> 5mm induration. 15. Human immunodeficiency virus (HIV) infection. 16. Current or past hepatitis B (HBV) infection. 17. Current or past hepatitis C virus (HCV) infection, except adequately treated HCV with documented sustained virologic response. 18. Active bacterial, viral, fungal, or opportunistic infection. 19. History of significant, recurrent, or chronic infection that may pose additional risks from participating in the study, in the opinion of the investigator. 20. History of severe psychiatric condition that would interfere with the participant's ability to comply with the study protocol, in the opinion of the investigator. 21. Current substance abuse, or history of substance abuse within 12 months of Visit 0. 22. Lack of peripheral venous access. 23. Pregnancy. 24. Breastfeeding. 25. Unwillingness to use a medically acceptable form of contraception for the duration of the study if female of child-bearing potential or if male with a partner of childbearing potential. 26. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

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Conditions

The condition(s) this trial relates to.

lupus nephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    New York, New York, 10032, United States

  • Emory University School of Medicine: Division of Rheumatology

    RECRUITING

    Atlanta, Georgia, 30307, United States

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

    RECRUITING

    Manhasset, New York, 11030, United States

  • Hospital for Special Surgery, New York: Division of Rheumatology

    NOT_YET_RECRUITING

    New York, New York, 10021, United States

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

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

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

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • UCLA Medical Center: Division of Rheumatology

    RECRUITING

    Los Angeles, California, 90095, United States

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

    RECRUITING

    La Jolla, California, 92093, United States

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

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago, Department of Medicine: Rheumatology

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado School of Medicine: Division of Rheumatology

    RECRUITING

    Aurora, Colorado, 80045, United States

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

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

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

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine: Section of Rheumatology

    WITHDRAWN

    New Haven, Connecticut, 06519, United States

  • of California, Irvine School of Medicine Division of Rheumatology

    RECRUITING

    Orange, California, 92868, United States

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