What is the mechanism of action of this treatment?

Common treatments for Lupus Nephritis, such as mycophenolate mofetil (MMF) and prednisone, work by suppressing the immune system to reduce inflammation and prevent immune-mediated damage to the kidneys. MMF inhibits the proliferation of T and B lymphocytes, which are crucial in the autoimmune response, while prednisone is a corticosteroid that reduces inflammation by inhibiting multiple inflammatory pathways. VIB4920, which is being studied in clinical trials, inhibits the CD40-CD40L interaction, a critical pathway in the activation of immune cells. This inhibition can potentially reduce the immune system's attack on kidney tissues, thereby decreasing inflammation and preventing further kidney damage. These mechanisms are vital for Lupus Nephritis patients as they help preserve kidney function and improve long-term outcomes.

What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis, such as mycophenolate mofetil (MMF), prednisone, cyclophosphamide, and rituximab, have several known side effects. MMF can cause gastrointestinal issues, infections, and bone marrow suppression. Prednisone, a corticosteroid, is associated with weight gain, hypertension, diabetes, osteoporosis, and increased infection risk. Cyclophosphamide can lead to bone marrow suppression, increased infection risk, hemorrhagic cystitis, and potential infertility. Rituximab, a monoclonal antibody, may cause infusion reactions, infections, and rare cases of progressive multifocal leukoencephalopathy (PML).

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis that focus on reducing inflammation and immune-mediated damage. Belimumab (Benlysta) is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and was approved for Lupus Nephritis in 2020. Additionally, voclosporin (Lupkynis), a calcineurin inhibitor, was approved in 2021 for its role in reducing proteinuria and preserving kidney function. These treatments, like VIB4920, aim to modulate the immune system to prevent further kidney damage.

What other types of research exist?

Promising alternatives to VIB4920 for Lupus Nephritis patients include SB431542, which regulates B cells and inhibits the TLR9/TGFβ1/PDGFB signaling, and the combination of mycophenolate mofetil (MMF) with prednisone. These options should be considered in consultation with a healthcare provider.

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VIB4920 for Lupus Nephritis (VIBRANT Trial)

Phase 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Classification of Systemic Lupus Erythematosus (SLE) by specified criteria

Age 18 years or older

Must not have

Unwillingness to use a medically acceptable form of contraception

Prior treatment with VIB4920

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 12, 24, 36, 48 and 60

Summary

This trial is testing a new drug called VIB4920, along with two other medications, MMF and prednisone, to treat kidney problems caused by lupus. The study involves people who have active lupus nephritis, a serious kidney condition. The treatment aims to reduce inflammation and calm the immune system to help improve kidney function. MMF has been established as an effective treatment for lupus nephritis, often used in combination with other medications like prednisone.

Who is the study for?

This trial is for adults over 18 with active lupus nephritis, diagnosed by specific criteria and a recent kidney biopsy. Participants must have had a COVID-19 vaccine as per CDC guidelines. Those with substance abuse history, certain infections like HIV or tuberculosis, past significant infections, or on treatments like biologics (except belimumab) are excluded.

What is being tested?

The VIBRANT study tests the effectiveness of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in treating lupus nephritis compared to a placebo. This double-blind study means neither participants nor researchers know who's receiving the real treatment versus the placebo.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible drug-specific adverse effects which could range from mild symptoms like nausea to more serious conditions depending on individual health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Systemic Lupus Erythematosus.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unwilling to use birth control.

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I have previously been treated with VIB4920.

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I frequently get serious infections.

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I have had tuberculosis in the past or have it now.

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I do not have any ongoing serious infections.

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I have or had hepatitis B.

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I have or had hepatitis C.

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I am HIV positive.

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I cannot take MMF or mycophenolate sodium due to health reasons.

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I am being treated with steroids for another health condition.

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My kidneys are in the final stage of failure.

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I have a history of cancer, but it may fit exceptions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 12, 24, 36, 48 and 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 12, 24, 36, 48 and 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12, 24, 36, 48 and 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving a complete renal response at week 36

Secondary study objectives

Anti-dsDNA antibodies

Change in Serum IgG over study participation

Change in Serum IgM over study participation

+11 more

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT04046549

22%

COVID-19

17%

Anaemia

17%

Leukopenia

17%

BK virus infection

17%

Hypophosphataemia

13%

Arthralgia

13%

Headache

Neutropenia

Urinary tract infection

Procedural pain

Post procedural urine leak

Hypokalaemia

Metabolic acidosis

Pain in extremity

Insomnia

Clostridium difficile infection

Urosepsis

Ileus

Cholecystitis acute

Kidney transplant rejection

Bacteraemia

Diabetic foot infection

Cytomegalovirus test positive

Hypervolaemia

Depression suicidal

Subcapsular renal haematoma

Ureteric stenosis

Arteriovenous fistula site complication

Blood creatinine increased

100%

80%

60%

40%

20%

Study treatment Arm

Belatacept+VIB4920

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VIB4920Experimental Treatment1 Intervention

Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.

Group II: VIB4920 PlaceboPlacebo Group1 Intervention

Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VIB4920

2019

Completed Phase 2

~350

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus Nephritis, such as mycophenolate mofetil (MMF) and prednisone, work by suppressing the immune system to reduce inflammation and prevent immune-mediated damage to the kidneys. MMF inhibits the proliferation of T and B lymphocytes, which are crucial in the autoimmune response, while prednisone is a corticosteroid that reduces inflammation by inhibiting multiple inflammatory pathways. VIB4920, which is being studied in clinical trials, inhibits the CD40-CD40L interaction, a critical pathway in the activation of immune cells. This inhibition can potentially reduce the immune system's attack on kidney tissues, thereby decreasing inflammation and preventing further kidney damage. These mechanisms are vital for Lupus Nephritis patients as they help preserve kidney function and improve long-term outcomes.