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NCT05201469 · ClinicalTrials.gov registry record · Phase 2
VIBRANT: VIB4920 for Active Lupus Nephritis
A Phase 2 study of Lupus Nephritis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 17
- Study locations
NCT05201469: Recruiting Phase 2 study of Lupus Nephritis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05201469 is a Phase 2 study of Lupus Nephritis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 74 participants, below the 308-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (76% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05201469, a Phase 2 study of Lupus Nephritis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 17
- Study locations
Study 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).
Primary Outcome
Complete renal response is defined as all of the following: 1. Urine protein-to-creatinine ratio (UPCR) \<= 0.5, based on a 24-hour urine collection 2. Estimated glomerular filtration rate (eGFR) \>= 120 ml/min/1.73 m\^2 or, if \< 120 ml/min/1.73 m\^2, then \>= 80 percent of the eGFR at baseline 3. Prednisone \<= 5 mg/day from Week 8, according to the prednisone dosing restrictions
Conditions Studied
Interventions
- DRUG VIB4920
- DRUG Placebo for VIB4920
Study Locations (17)
California
- University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology - La Jolla
- UCLA Medical Center: Division of Rheumatology - Los Angeles
- of California, Irvine School of Medicine Division of Rheumatology - Orange
- University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center - San Francisco
New York
- Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases - Manhasset
- Hospital for Special Surgery, New York: Division of Rheumatology - New York
- Columbia University Medical Center: Department of Medicine, Division of Rheumatology - New York
Pennsylvania
- Penn State Health Milton S. Hershey Medical Center: Division of Rheumatology - Hershey
- Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology - Philadelphia
Colorado
- University of Colorado School of Medicine: Division of Rheumatology - Aurora
Connecticut
- Yale University School of Medicine: Section of Rheumatology - New Haven
Florida
- University of Miami Miller School of Medicine: Nephrology & Hypertension Division - Miami
Georgia
- Emory University School of Medicine: Division of Rheumatology - Atlanta
Illinois
- University of Chicago, Department of Medicine: Rheumatology - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What NCT05201469 shows while recruiting
NCT05201469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 308-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 2 interventions - of which VIB4920 is the first listed.
NCT05201469 lists 17 locations in 11 states (California, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05201469 about?
NCT05201469 is a clinical study titled "VIBRANT: VIB4920 for Active Lupus Nephritis". 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).
What is the current status of trial NCT05201469?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2022-05-16. Estimated completion is 2027-03.
What conditions does trial NCT05201469 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT05201469?
The interventions under investigation include: VIB4920 (DRUG), Placebo for VIB4920 (DRUG).
Who is sponsoring clinical trial NCT05201469?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05201469 being conducted?
This trial has 17 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05201469's enrollment target sits among peer trials
74 17th of 30 higher than 14 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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