A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis (ITN091AI)
National Institute of Allergy and Infectious Diseases (NIAID)
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).
Description
Seventy-four eligible participants with active lupus nephritis (LN) will be randomized to receive VIB4920 1500 mg or placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will receive a total of 1000 mg of methylprednisolone according to either of the following schedules: * 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 1…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugVIB4920
Participants will receive 1500 mg of VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone
- DrugPlacebo 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
Locations (17)
- University of California San Diego School of Medicine: Division of Rheumatology, Allergy and ImmunologyLa Jolla, California
- UCLA Medical Center: Division of RheumatologyLos Angeles, California
- of California, Irvine School of Medicine Division of RheumatologyOrange, California
- University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research CenterSan Francisco, California
- University of Colorado School of Medicine: Division of RheumatologyAurora, Colorado
- Yale University School of Medicine: Section of RheumatologyNew Haven, Connecticut