NCT05201469 · National Institute of Allergy and Infectious Diseases (NIAID)
VIBRANT: VIB4920 for Active Lupus Nephritis
(VIBRANT)
What this study is about
This is a multi-center where neither patients nor doctors know which treatment is given placebo controlled clinical trial evaluating the effectiveness of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in achieving a renal response in participants with active lupus nephritis (LN).
View original scientific description
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).
Interventions
DRUG
VIB4920
Participants will receive 1500 mg of VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone
DRUG
Placebo for VIB4920
Participants will receive placebo for VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone
Primary outcome measures
Proportion of participants achieving a complete renal response at week 36
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. Contrain
Where
- La Jolla, California
- Los Angeles, California
- Orange, California
- San Francisco, California
- Aurora, Colorado
- New Haven, Connecticut
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Ann Arbor, Michigan
- St Louis, Missouri
- Manhasset, New York
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2025 · Source of record for eligibility and locations