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Lupus NephritisPhase 2VIBRANTNCT05201469

VIBRANT: VIB4920 for Active Lupus Nephritis

A Phase 2 study testing VIB4920 in people with Lupus Nephritis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Nephritis
What is being tested?
VIB4920
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
17 sitesUnited States
Study dates
15 Dec 2022to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 39Show fewer
  • 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.
  • Positive T-SPOT.TB test.
  • Positive purified protein derivation (PPD) tuberculin test, defined as > 5mm induration.
  • Human immunodeficiency virus (HIV) infection.
  • Current or past hepatitis B (HBV) infection.
  • Current or past hepatitis C virus (HCV) infection, except adequately treated HCV with documented sustained virologic response.
  • Active bacterial, viral, fungal, or opportunistic infection.
  • History of significant, recurrent, or chronic infection that may pose additional risks from participating in the study, in the opinion of the investigator.
  • 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.
  • Current substance abuse, or history of substance abuse within 12 months of Visit 0.
  • Lack of peripheral venous access.
  • Pregnancy.
  • Breastfeeding.
  • 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.
  • 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.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

17 sites in 1 country

United States17 sites, 16 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Angela Westover, 734-936-6467, funke@med.umich.edu

    Sydney Singal, ssingal@med.umich.edu

    Recruiting

  • Emory University School of Medicine: Division of Rheumatology

    Atlanta, Georgia, 30307

    Chris Chin, 404-712-2949, chris.chi.chin@emory.edu

    Toby Amoss, r.toby.amoss@emory.edu

    Recruiting

  • University of Colorado School of Medicine: Division of Rheumatology

    Aurora, Colorado, 80045

    Elizabeth Wagner, 303-724-7790, elizabeth.c.wagner@cuanschutz.edu

    Jennyleigh Santa Rosa, Jennyleigh.santarosa@cuanschutz.edu

    Recruiting

  • University of South Carolina

    Charleston, South Carolina, 29425

    Stephanie Dezzutti, 843-792-8997, brays@musc.edu

    Lori Ann Ueberroth, 843-792-1964, ueberro@musc.edu

    Recruiting

  • University of Chicago, Department of Medicine: Rheumatology

    Chicago, Illinois, 60637

    Taylor Trunzo, (773) 795-2051, Taylor.Trunzo@bsd.uchicago.edu

    Kichul Ko

    Recruiting

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

    Hershey, Pennsylvania, 17033

    Jamie Carter, 717-531-4921, jcarter3@pennstatehealth.psu.edu

    215-615-4938

    Recruiting

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

    La Jolla, California, 92093

    Linda Mendoza, 858-246-2389, lnmendoza@health.ucsd.edu

    Bosco Trinh, botrinh@health.ucsd.edu

    Recruiting

  • UCLA Medical Center: Division of Rheumatology

    Los Angeles, California, 90095

    Aima Ohiwerei, 310-825-2598, aohiwerei@mednet.ucla.edu

    Lori Sahakian, 310-794-9236, Lsahakian@mednet.ucla.edu

    Recruiting

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

    Manhasset, New York, 11030

    Sanita Kandasami, 516-562-2401, skandasami@northwell.edu

    Andrew Shaw, anshaw@northwell.edu

    Recruiting

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

    Miami, Florida, 33136

    Carlos Bidot, 305-243-8793, cbidot2@med.miami.edu

    Anres Rivera Cruz, axr2930@miami.edu

    Recruiting

  • Yale University School of Medicine: Section of Rheumatology

    New Haven, Connecticut, 06519

    Withdrawn

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

    New York, New York, 10021

    Natasha Zamin, 212-774-2967, zarrinn@hss.edu

    Christele Felix, 646-714-6196, felixc@hss.edu

    Not yet recruiting

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

    New York, New York, 10032

    Ellen Montgomery, (212)-342-9051, em4066@cumc.columbia.edu

    Stephen Suh, sks2231@cumc.columbia.edu

    Recruiting

  • of California, Irvine School of Medicine Division of Rheumatology

    Orange, California, 92868

    Walid Roshan, 714-509-6271, ahmadwar@hs.uci.edu

    Bryan Robles, bsrobles@hs.uci.edu

    Recruiting

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

    Philadelphia, Pennsylvania, 19140

    Julia Aruta, 215-707-7576, julia.aruta@temple.edu

    Zoe Pfeffer, 267-242-2902, zoe.pfeffer@tuhs.temple.edu

    Recruiting

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

    San Francisco, California, 94143

    Lidia Espino, 415-502-5108, Lidia.Espino@ucsf.edu

    Alex Yamana, 415-502-1886, Alex.Yamana@ucsf.edu

    Recruiting

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

    St Louis, Missouri, 63110

    Michelle Bloom, 314-286-0875, mbloom@wustl.edu

    Tingting Li

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis (ITN091AI)

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).

Read the detailed description

Seventy-four eligible participants with active lupus nephritis (LN) will be randomized to receive VIB4920 1500 mg or placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will receive a total of 1000 mg of methylprednisolone according to either of the following schedules:

  • 1000 mg methylprednisolone IV at Day 0, or
  • 500 mg methylprednisolone IV at Day 0 and at Day 1.

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 also receive MMF 2-3 g per day and will receive prednisone 25 mg/d beginning on Day 0, or on the day after completion of methylprednisolone. Prednisone will be tapered to 5 mg/d by Week 8.

Conditions
Lupus Nephritis
Being tested
VIB4920, Placebo for VIB4920
Keywords
Lupus Nephritis, Mycophenolate mofetil, VIB4920
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIB4920Drug

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

  • Placebo for VIB4920Drug

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

Study groups in NCT05201469
Study groupRoleWhat they receive
VIB4920ExperimentalParticipants 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.
Receives: Drug: VIB4920
VIB4920 PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo for VIB4920

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 36

Secondary outcomes (14)

  1. Proportion of participants who achieve a complete renal response

    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 Week 0
    3. Prednisone tapered to <= 5 mg/day by Week 8, and adherence to the prednisone dosing restrictions

    Measured: Weeks 12, 24, 48, and 60

  2. Proportion of participants who achieve an overall renal response

    Overall renal response is defined as all of the following:

    1. >= 50 percent improvement in the urine protein-to-creatinine ratio (UPCR) compared to baseline, 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, and
    3. Prednisone <= 5 mg/day from Week 8, according to the prednisone dosing restrictions

    Measured: Weeks 12, 24, 36, 48 and 60

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

    BLISS-LN primary efficacy renal response (PERR) defined as all of the following:

    1. UPCR ≤ 0.7, and
    2. eGFR ≥ 60 ml/min/1.73m2, or if < 60 ml/min/1.73m2, then ≥ 80% of the eGFR at baseline, and
    3. no receipt of a prohibited immunosuppressive or immunomodulatory medication

    Measured: Weeks 12, 24, 36, 48, and 60

  4. Urine Protein-to-Creatinine Ratio (UPCR)

    Based on 24-hour urine collection

    Measured: Weeks 12, 24, 36, 48, and 60

  5. Anti-dsDNA antibodies

    The change in the proportion of participants who had a negative anti-dsDNA test will be summarized by arm, and will be analyzed using an exact conditional logistic regression model

    Measured: Weeks 12, 24, 36, 48, and 60

  6. Change in proportion of participants with lower C3 levels after treatment initiation

    The change in the proportion of participants who were hypocomplementemic for C3 and C4 after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an exact conditional logistic regression model

    Measured: Weeks 12, 24, 36, 48, and 60

  7. Change in proportion of participants with lower C4 levels after treatment initiation

    The change in the proportion of participants who were hypocomplementemic for C3 and C4 after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an exact conditional logistic regression model

    Measured: Weeks 12, 24, 36, 48, and 60

  8. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    The change in SLEDAI-2K scores after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an analysis of covariance (ANCOVA) model

    Measured: Weeks 12, 24, 36, 48, and 60

  9. Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for Systemic Lupus Erythematosus (SLICC/ACR-DI)

    The change in SLICC/ACR-DI scores after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an ANCOVA model

    Measured: Weeks 24 and 60

  10. Proportion of participants who experience treatment failures

    Treatment failure is defined as any one of the following:

    1. Receipt of SLE rescue therapy
    2. End-stage renal disease (ESRD), defined as eGFR < 20 ml/min/1.73m2
    3. Worsening of proteinuria or eGFR from Week 24 onward, defined as either:
    4. confirmed ≥ 50% increase in the UPCR to a value ≥ 3.0 compared to Visit -1, or
    5. confirmed ≥ 30% increase in eGFR to a value of < 60, compared to Visit -1

    Measured: Week 0 to Week 60

  11. Number of participants who experience at least one serious adverse event

    The number of participants who experienced at least one SAE and the number of participants who experienced at least one AESI will be analyzed using a Fisher's exact test.

    Measured: Week 0 to Week 60

  12. Number of participants who experience at least one adverse Events of Special Interest

    Adverse Events of Special Interests include:

    1. Anaphylaxis
    2. Grade 3 or greater infusion reaction
    3. Grade 3 or greater hypersensitivity reaction
    4. Grade 3 or greater infection
    5. Thromboembolic event

    Measured: Week 0 to Week 60

  13. Change in Serum IgM over study participation

    Serum IgM levels will be analyzed using a longitudinal mixed effects model with the test results at the time points as the dependent variable

    Measured: Weeks 12, 24, 36, 48, and 60

  14. Change in Serum IgG over study participation

    Serum IgG levels will be analyzed using a longitudinal mixed effects model with the test results at the time points as the dependent variable

    Measured: Weeks 12, 24, 36, 48, and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start15 Dec 2022
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201469
Sponsor's protocol ID
DAIT ITN091AI
Acronym
VIBRANT
Status last verified
Sep 2026
First submitted
7 Jan 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical mechanistic data from NIAID/DAIT-funded grants and contracts

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIB4920 in people with Lupus Nephritis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving a complete renal response at week 36 (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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