RECRUITING

VIBRANT: VIB4920 for Active Lupus Nephritis

Conditions

Lupus Nephritis Mycophenolate mofetil VIB4920

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-05-16

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05201469

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 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.	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. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational and are not exclusionary. 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 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.

Inclusion Criteria

Exclusion Criteria

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.
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.

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. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational and are not exclusionary.
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 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.

Contacts and Locations

Principal Investigator

Maria Dall'Era, M.D.

STUDY_CHAIR

University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

Betty Diamond, M.D.

STUDY_CHAIR

Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases

David Wofsy, M.D.

STUDY_CHAIR

University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

Study Locations (Sites)

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

University of California, Irvine School of Medicine Division of Rheumatology

Orange, California, 92868

United States

University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

San Francisco, California, 94143

United States

University of Colorado School of Medicine: Division of Rheumatology

Aurora, Colorado, 80045

United States

Yale University School of Medicine: Section of Rheumatology

New Haven, Connecticut, 06519

United States

University of Miami Miller School of Medicine: Nephrology & Hypertension Division

Miami, Florida, 33136

United States

Emory University School of Medicine: Division of Rheumatology

Atlanta, Georgia, 30307

United States

University of Chicago, Department of Medicine: Rheumatology

Chicago, Illinois, 60637

United States

Washington University School of Medicine in St. Louis: Division of Nephrology

Saint Louis, Missouri, 63110

United States

Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases

Manhasset, New York, 11030

United States

Hospital for Special Surgery, New York: Division of Rheumatology

New York, New York, 10021

United States

Columbia University Medical Center: Department of Medicine, Division of Rheumatology

New York, New York, 10032

United States

Ohio State University

Columbus, Ohio, 43201

United States

Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology

Hershey, Pennsylvania, 17033

United States

Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology

Philadelphia, Pennsylvania, 19140

United States

University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Maria Dall'Era, M.D., STUDY_CHAIR, University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Betty Diamond, M.D., STUDY_CHAIR, Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
David Wofsy, M.D., STUDY_CHAIR, University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-16

Study Completion Date2027-03

Study Record Updates

Study Start Date2022-05-16

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Lupus Nephritis
Mycophenolate mofetil
VIB4920

Additional Relevant MeSH Terms

Lupus Nephritis