A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis (ITN091AI)
Who is this study for? Patients with active lupus nephritis
What treatments are being studied? VIB4920
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
∙ Individuals who meet all of the following criteria are eligible for enrollment as study participants:
• Age 18 years or older.
• 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.
• UPCR ≥ 1.0 based on a 24-hour urine collection at Visit -1 or within 14 days prior to Visit -1.
• Renal biopsy within 24 weeks prior to Visit -1 of ISN/RPS LN with both of the following:
‣ Class III, Class IV, or Class V in combination with Class III or IV, and
⁃ Modified NIH Activity Index ≥ 1.
Locations
United States
California
University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
NOT_YET_RECRUITING
La Jolla
UCLA Medical Center: Division of Rheumatology
NOT_YET_RECRUITING
Los Angeles
University of California, Irvine School of Medicine Division of Rheumatology
NOT_YET_RECRUITING
Orange
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
RECRUITING
San Francisco
Colorado
University of Colorado School of Medicine: Division of Rheumatology
RECRUITING
Aurora
Connecticut
Yale University School of Medicine: Section of Rheumatology
RECRUITING
New Haven
Florida
University of Miami Miller School of Medicine: Nephrology & Hypertension Division
RECRUITING
Miami
Georgia
Emory University School of Medicine: Division of Rheumatology
RECRUITING
Atlanta
Illinois
University of Chicago, Department of Medicine: Rheumatology
RECRUITING
Chicago
Missouri
Washington University School of Medicine in St. Louis: Division of Nephrology
RECRUITING
St Louis
New York
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
RECRUITING
Manhasset
Columbia University Medical Center: Department of Medicine, Division of Rheumatology
RECRUITING
New York
Hospital for Special Surgery, New York: Division of Rheumatology
NOT_YET_RECRUITING
New York
Ohio
Ohio State University
NOT_YET_RECRUITING
Columbus
Pennsylvania
Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology
NOT_YET_RECRUITING
Hershey
Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology
NOT_YET_RECRUITING
Philadelphia
South Carolina
University of South Carolina
RECRUITING
Charleston
Time Frame
Start Date: 2022-05-16
Estimated Completion Date: 2027-03
Participants
Target number of participants: 74
Treatments
Experimental: 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.
Placebo_comparator: 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.
Authors
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)