Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
74 participants
INTERVENTIONAL
2022-05-16
2027-03-31
Brief Summary
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Detailed Description
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* 1000 mg methylprednisolone IV at Day 0, or
* 500 mg methylprednisolone IV at Day 0 and at Day 1.
Participants who previously received 1000 mg of methylprednisolone IV within 42 days of Visit 0 will not receive additional methylprednisolone IV on Day 0. Participants who previously received less than 1000 mg of methylprednisolone IV within 42 days of Visit 0 will receive an additional dose of methylprednisolone IV at Day 0, according to the following formula, where X is the intravenous dose previously received and Y is the intravenous dose administered on Day 0: 1000 mg - X = Y. Participants will also receive MMF 2-3 g per day and will receive prednisone 25 mg/d beginning on Day 0, or on the day after completion of methylprednisolone. Prednisone will be tapered to 5 mg/d by Week 8.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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VIB4920
Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Participants who previously received 1000 mg of methylprednisolone IV within 42 days of Visit 0 will not receive additional methylprednisolone IV on Day 0. Participants who previously received less than 1000 mg of methylprednisolone IV within 42 days of Visit 0 will receive an additional dose of methylprednisolone IV at Day 0, according to the following formula, where X is the intravenous dose previously received and Y is the intravenous dose administered on Day 0: 1000 mg - X = Y. Participants will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to 5 mg per day by Week 8. The prednisone dose may be tapered more rapidly and to a dose lower than 5 mg/d, at the discretion of the site investigator. Prednisone of no more than 5 mg/d will be continued until Week 60.
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
VIB4920 Placebo
Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Participants who previously received 1000 mg of methylprednisolone IV within 42 days of Visit 0 will not receive additional methylprednisolone IV on Day 0. Participants who previously received less than 1000 mg of methylprednisolone IV within 42 days of Visit 0 will receive an additional dose of methylprednisolone IV at Day 0, according to the following formula, where X is the intravenous dose previously received and Y is the intravenous dose administered on Day 0: 1000 mg - X = Y. Participants will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to 5 mg per day by Week 8. The prednisone dose may be tapered more rapidly and to a dose lower than 5 mg/d, at the discretion of the site investigator. Prednisone of no more than 5 mg/d will be continued until Week 60.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion 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 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
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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Maria Dall'Era, M.D.
Role: STUDY_CHAIR
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Betty Diamond, M.D.
Role: STUDY_CHAIR
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
David Wofsy, M.D.
Role: STUDY_CHAIR
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Locations
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University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
La Jolla, California, United States
UCLA Medical Center: Division of Rheumatology
Los Angeles, California, United States
of California, Irvine School of Medicine Division of Rheumatology
Orange, California, United States
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
San Francisco, California, United States
University of Colorado School of Medicine: Division of Rheumatology
Aurora, Colorado, United States
Yale University School of Medicine: Section of Rheumatology
New Haven, Connecticut, United States
University of Miami Miller School of Medicine: Nephrology & Hypertension Division
Miami, Florida, United States
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States
University of Chicago, Department of Medicine: Rheumatology
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis: Division of Nephrology
St Louis, Missouri, United States
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Manhasset, New York, United States
Hospital for Special Surgery, New York: Division of Rheumatology
New York, New York, United States
Columbia University Medical Center: Department of Medicine, Division of Rheumatology
New York, New York, United States
Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology
Hershey, Pennsylvania, United States
Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology
Philadelphia, Pennsylvania, United States
University of South Carolina
Charleston, South Carolina, United States
Countries
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Facility Contacts
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Linda Mendoza
Role: primary
Bosco Trinh
Role: backup
Aima Ohiwerei
Role: primary
Lori Sahakian
Role: backup
Walid Roshan
Role: primary
Bryan Robles
Role: backup
Lidia Espino
Role: primary
Alex Yamana
Role: backup
Elizabeth Wagner
Role: primary
Jennyleigh Santa Rosa
Role: backup
Lindsie Boerger
Role: primary
Carlos Bidot
Role: primary
Anres Rivera Cruz
Role: backup
Chris Chin
Role: primary
Toby Amoss
Role: backup
Taylor Trunzo
Role: primary
Angela Westover
Role: primary
Sydney Singal
Role: backup
Michelle Bloom
Role: primary
Sanita Kandasami
Role: primary
Andrew Shaw
Role: backup
Natasha Zamin
Role: primary
Christele Felix
Role: backup
Ellen Montgomery
Role: primary
Stephen Suh
Role: backup
Jamie Carter
Role: primary
Role: backup
Julia Aruta
Role: primary
Zoe Pfeffer
Role: backup
Stephanie Dezzutti
Role: primary
Lori Ann Ueberroth
Role: backup
Related Links
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Immune Tolerance Network (ITN)
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation (DAIT)
Other Identifiers
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DAIT ITN091AI
Identifier Type: -
Identifier Source: org_study_id