← Back to Search

VIB4920 for Lupus Nephritis (VIBRANT Trial)

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Classification of Systemic Lupus Erythematosus (SLE) by specified criteria
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 48, and 60
Awards & highlights

VIBRANT Trial Summary

This trial is testing a new drug to see if it's effective in treating lupus nephritis, a kidney disease. The trial is double-blind, meaning neither the patients nor the doctors know who is receiving the real drug or the placebo.

Who is the study for?
This trial is for adults over 18 with active lupus nephritis, diagnosed by specific criteria and a recent kidney biopsy. Participants must have had a COVID-19 vaccine as per CDC guidelines. Those with substance abuse history, certain infections like HIV or tuberculosis, past significant infections, or on treatments like biologics (except belimumab) are excluded.Check my eligibility
What is being tested?
The VIBRANT study tests the effectiveness of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in treating lupus nephritis compared to a placebo. This double-blind study means neither participants nor researchers know who's receiving the real treatment versus the placebo.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible drug-specific adverse effects which could range from mild symptoms like nausea to more serious conditions depending on individual health factors.

VIBRANT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Systemic Lupus Erythematosus.
Select...
I am 18 years old or older.

VIBRANT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, 36, 48, and 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, 48, and 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
BLISS-LN primary efficacy renal response (PERR)
Change in Serum IgM over study participation
Change in proportion of participants who have negative Anti-dsDNA antibodies post treatment initiation
+11 more

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT04046549
22%
COVID-19
17%
Leukopenia
17%
BK virus infection
17%
Anaemia
17%
Hypophosphataemia
13%
Arthralgia
13%
Headache
9%
Urinary tract infection
9%
Metabolic acidosis
9%
Insomnia
9%
Procedural pain
9%
Post procedural urine leak
9%
Hypokalaemia
9%
Neutropenia
9%
Pain in extremity
4%
Bacteraemia
4%
Clostridium difficile infection
4%
Blood creatinine increased
4%
Subcapsular renal haematoma
4%
Cytomegalovirus test positive
4%
Ureteric stenosis
4%
Arteriovenous fistula site complication
4%
Ileus
4%
Cholecystitis acute
4%
Hypervolaemia
4%
Kidney transplant rejection
4%
Depression suicidal
4%
Diabetic foot infection
4%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept+VIB4920

VIBRANT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB4920Experimental Treatment1 Intervention
Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.
Group II: VIB4920 PlaceboPlacebo Group1 Intervention
Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIB4920
2019
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,483,028 Total Patients Enrolled
4 Trials studying Lupus Nephritis
187 Patients Enrolled for Lupus Nephritis
Maria Dall'Era, M.D.Study ChairUniversity of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
1 Previous Clinical Trials
43 Total Patients Enrolled
1 Trials studying Lupus Nephritis
43 Patients Enrolled for Lupus Nephritis
Betty Diamond, M.D.Study ChairFeinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
1 Previous Clinical Trials
43 Total Patients Enrolled
1 Trials studying Lupus Nephritis
43 Patients Enrolled for Lupus Nephritis

Media Library

Placebo for VIB4920 Clinical Trial Eligibility Overview. Trial Name: NCT05201469 — Phase 2
Lupus Nephritis Research Study Groups: VIB4920 Placebo, VIB4920
Lupus Nephritis Clinical Trial 2023: Placebo for VIB4920 Highlights & Side Effects. Trial Name: NCT05201469 — Phase 2
Placebo for VIB4920 2023 Treatment Timeline for Medical Study. Trial Name: NCT05201469 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any deleterious effects associated with VIB4920 usage?

"The safety of VIB4920 has been assessed with a score of 2 since clinical data verifies its security, although the drug's efficacy has yet to be established."

Answered by AI

How many locations in the city are implementing this research experiment?

"There are 15 locations enrolling patients in this trial, such as the University of Miami Miller School of Medicine: Nephrology & Hypertension Division (Miami), Washington University School of Medicine in St. Louis: Division of Nephrology (St. Louis) and the University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology (La Jolla). Additionally, there are a dozen other medical centers taking part in this study."

Answered by AI

How many participants are included in the current clinical trial?

"Affirmative. According to clinicaltrials.gov, this project is actively seeking eligible participants after being first posted on May 16th 2022 and recently updated on November 21st 2022. A total of 114 individuals are required for the study at 15 different medical locations."

Answered by AI

Are new participants being admitted to this investigation?

"Clinicaltrials.gov shows that recruitment for this medical trial is still ongoing, with the initial posting occurring on May 16th 2022 and most recent update taking place November 21st of the same year."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago, Department of Medicine: Rheumatology
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~41 spots leftby Aug 2026