RecruitingPhase 2

VIBRANT: VIB4920 for Active Lupus Nephritis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether VIB4920, added to mycophenolate mofetil (MMF) and prednisone, helps the kidneys in adults with active lupus nephritis—kidney swelling caused by lupus. It compares VIB4920 with a placebo, a treatment with no active study drug.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have lupus diagnosed using one of the accepted sets of medical rules listed for the study.
  • A 24-hour urine test shows a protein-to-creatinine ratio of at least 1.0, a sign of protein leaking into urine. The test must be at the screening visit or within 14 days before it.
  • A kidney tissue sample taken within 24 weeks before screening shows class III or IV lupus nephritis, with or without class V. It must also show an activity score of at least 1, meaning the disease is active.

Who can't join

  • You cannot give written consent or follow study rules, cannot safely take MMF or mycophenolate sodium, or have had a severe allergy to an ingredient in VIB4920.
  • You have taken VIB4920 before, recently used certain immune-system or experimental drugs, or had a live vaccine within 4 weeks before Visit 0.
  • You have another illness needing steroid treatment throughout the body, very poor kidney function, a past transplant, or current or past cancer. Some fully treated skin cancers and early cervical cancers are allowed.
  • You have certain blood clot risks, including recent or repeated clots, certain inherited clotting problems, antiphospholipid syndrome, or major surgery or inability to move within 12 weeks before Visit 0.
  • Blood tests show very low levels of certain immune cells, red blood cells, or platelets, which help blood clot; or liver test levels are at least twice the upper normal limit.
  • You have current or past TB or hepatitis B, HIV, an active infection, or a history of serious or repeated infections that adds risk. Past hepatitis C is allowed only if treatment successfully cleared it.
  • You have a severe mental health condition that prevents following study rules, current substance abuse or substance abuse within 12 months before Visit 0, no usable vein for study procedures, or another health issue the study doctor considers unsafe.
  • You are pregnant or breastfeeding, or will not use accepted birth control during the study when you or your partner could become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (17)

CA

CO

CT

FL

GA

IL

MI

MO

NY

PA

SC