Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

Up to 114 eligible participants with active lupus nephritis (LN) will receive induction therapy with mycophenolate mofetil (MMF) and methylprednisolone beginning at Week 0.Participants will also receive prednisone 25 mg per day beginning at Week 0 and tapered to 5 mg per day at Week 8. Participants will be assessed at Week 8 for a renal response. Sixty-six participants with a urine protein-to-creatinine ratio (UPCR) > 0.75 will be randomized 2:1 to receive VIB4920 versus placebo at Week 10. Participants who are not eligible for randomization will complete study participation after the Week 8 study visit, and further care will be provided according to the judgment of the site investigator or treating physician. Randomized participants will receive VIB4920 1500 mg or placebo intravenously at Weeks 10, 12, 14, 18, 22, 26, 30, and 34, and will continue MMF 2-3 g per day and prednisone 5 mg per day. The primary endpoint will be assessed at Week 38, and participants followed until Week 60.

Keywords

Lupus Nephritis Mycophenolate mofetil VIB4920 Nephritis

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Classification of Systemic Lupus Erythematosus (SLE) by any of the following criteria:
  2. the 1997 update of the 1982 American College of Rheumatology (ACR) criteria
  3. or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria
  4. or the 2019 European League Against Rheumatism (EULAR)/ACR criteria
  5. Urine protein-to-creatinine ratio (UPCR) >=1.5 based on a 24-hour urine collection at Visit -1 or within 14 days prior to Visit -1
  6. Renal biopsy documentation at Visit 1 of ISN/RPS LN with both of the following:
  7. Class III, Class IV, or Class V in combination with Class III or IV, and
  8. Modified NIH Activity Index >= 1

You CAN'T join if...

  1. Inability or unwillingness to give written informed consent or comply with study protocol
  2. Contraindication to treatment with mycophenolate mofetil (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 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. End stage renal disease, defined as Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2

  10. . History of transplantation
  11. . The following risks for thromboembolic events:
  12. Recent or recurrent deep venous thrombosis or arterial thromboembolism.
  13. Immobilization or major surgery within 12 weeks prior to Visit 0.
  14. History of congenital or inherited deficiency of antithrombin III, protein S, or protein C.
  15. History of anti-phospholipid syndrome.
  16. Any one of the following anti-phospholipid antibodies:
  17. Positive lupus anticoagulant test, or

ii. Anti-beta2-glycoprotein I IgG ELISA titer >= 40 GPL, or

iii. Anti-cardiolipin IgG ELISA titer >= 40 GPL

  1. . History of a severe allergy or hypersensitivity reaction to any component of the VIB4920 formulation
  2. . Any one of the following laboratory abnormalities:
  3. Peripheral B cell count < 5/mcl
  4. Neutropenia (absolute neutrophil count < 1000/mm3)

  5. Anemia (hemoglobin < 8 g/dL)
  6. Thrombocytopenia (platelets < 50,000/mm3)

  7. Aspartate aminotransferase or alanine aminotransferase >= 2x upper limit of normal
  8. . Evidence of current or prior tuberculosis infection, including any of the following:
  9. Positive QuantiFERON-TB Gold or TB Gold Plus test
  10. Positive T-SPOT.TB test
  11. Positive purified protein derivation (PPD) tuberculin test, defined as > 5mm induration
  12. . Human immunodeficiency virus (HIV) infection
  13. . Current or past hepatitis B (HBV) infection
  14. . Current or past hepatitis C virus (HCV) infection, except adequately treated HCV with documented sustained virologic response
  15. . Active bacterial, viral, fungal, or opportunistic infection
  16. . History of significant, recurrent, or chronic infection that may pose additional risks from participating in the study, in the opinion of the investigator
  17. . 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
  18. . Current substance abuse, or history of substance abuse within 12 months of Visit 0
  19. . Lack of peripheral venous access
  20. . Pregnancy
  21. . Breastfeeding
  22. . 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 child- bearing potential
  23. . 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

Locations

  • University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
    La Jolla California 92093 United States
  • UCLA Medical Center: Division of Rheumatology
    Los Angeles California 90095 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
Immune Tolerance Network (ITN) National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT)
ID
NCT05201469
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 114 study participants
Last Updated