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New treatment option for Lupus Nephritis
Official title VIBRANT: VIB4920 for Active Lupus Nephritis
ClinicalTrials.gov ID: NCT05201469
What this study is testing
What is VIB4920?
VIB4920 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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:
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Manhasset, New York, United States
- New York, New York, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.