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Monoclonal Antibodies
Nipocalimab for Lupus Nephritis
Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
COVID-19 infection: During the 6 weeks prior to baseline, have had any of the following (a) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features of COVID-19 without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection
Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24 and week 52
Awards & highlights
Summary
This trial is testing nipocalimab, a medicine that reduces harmful antibodies, in patients with active Lupus Nephritis, a severe kidney condition caused by lupus. The study will last over a year and will monitor safety and effectiveness.
Who is the study for?
Adults with active Lupus Nephritis can join this trial. They should be up-to-date on vaccinations, taking a stable dose of prednisone (<=60 mg/day), and have had a kidney biopsy showing specific types of nephritis within the last 6 months. Participants must not have certain infections or other inflammatory diseases, nor received cyclophosphamide recently.
What is being tested?
The study is testing the effectiveness of Nipocalimab compared to a placebo in treating Lupus Nephritis. All participants will continue their standard-of-care treatment alongside either Nipocalimab or placebo to see if there's an improvement in their condition.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions similar to other immune therapies such as infusion-related reactions, increased risk of infections, and possible interference with normal immune responses.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had COVID-19 or been in close contact with someone who has in the last 6 weeks.
Select...
I do not have conditions like RA, PsA, lupus, psoriasis, Crohn's disease, or active Lyme disease.
Select...
I have had infections like histoplasmosis or coccidioidomycosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24 and week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving Complete Renal Response (CRR)
Secondary study objectives
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
Percentage of Participants Achieving CRR
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions
Participants will receive nipocalimab dose 2 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.
Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions
Participants will receive nipocalimab dose 1 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.
Group III: Group 1: PlaceboPlacebo Group2 Interventions
Participants will receive placebo intravenously (IV) every two weeks (q2w) from Week 0 through Week 50 along with standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) until unblinding of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~420
Standard-of-care treatment
2018
N/A
~120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Lupus Nephritis (LN) include corticosteroids, cyclophosphamide, and mycophenolate mofetil, which suppress the immune system to reduce inflammation and prevent kidney damage. Nipocalimab, a novel treatment under study, inhibits the neonatal Fc receptor (FcRn) to reduce pathogenic IgG antibodies.
This targeted approach is significant for LN patients as it addresses the root cause of the immune response, potentially offering more effective treatment with fewer side effects compared to traditional immunosuppressive therapies.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
988 Previous Clinical Trials
6,385,877 Total Patients Enrolled
3 Trials studying Lupus Nephritis
158 Patients Enrolled for Lupus Nephritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
754 Previous Clinical Trials
3,961,645 Total Patients Enrolled
2 Trials studying Lupus Nephritis
58 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am up-to-date with my vaccinations, including COVID-19, as per local guidelines.I have taken oral cyclophosphamide in the last 3 months or IV cyclophosphamide in the last 6 months.Your urine test shows a high level of protein compared to creatinine, measured twice during screening.I have had COVID-19 or been in close contact with someone who has in the last 6 weeks.I am on a low dose of prednisone (<=60 mg/day or 1 mg/kg/day, whichever is lower) for at least 6 weeks, with a stable dose for the last 2 weeks.I have been on a stable dose of ACE inhibitor or ARB for at least 2 weeks.I've needed steroids 3+ times in the last year for conditions other than Lupus Nephritis.I do not have conditions like RA, PsA, lupus, psoriasis, Crohn's disease, or active Lyme disease.My kidney biopsy shows Class III or IV nephritis.I have had infections like histoplasmosis or coccidioidomycosis.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Placebo
- Group 2: Group 2: Nipocalimab Dose 1
- Group 3: Group 3: Nipocalimab Dose 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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