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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24 and week 52
Awards & highlights

Study Summary

This trial will test whether nipocalimab is better than placebo at treating Lupus Nephritis.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Complete Renal Response (CRR)
Secondary outcome measures
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 more

Trial 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
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,228 Total Patients Enrolled
3 Trials studying Lupus Nephritis
158 Patients Enrolled for Lupus Nephritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,825 Total Patients Enrolled
2 Trials studying Lupus Nephritis
58 Patients Enrolled for Lupus Nephritis

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04883619 — Phase 2
Lupus Nephritis Research Study Groups: Group 1: Placebo, Group 2: Nipocalimab Dose 1, Group 3: Nipocalimab Dose 2
Lupus Nephritis Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT04883619 — Phase 2
Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883619 — Phase 2

Frequently Asked Questions

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

Does this research include data from elderly patients?

"Eligibility for this study requires that patients are between 18-75 years old; there are 9 other studies available for patients under 18 and 38 additional trials for those over 65."

Answered by AI

What is Nipocalimab's current stage of development?

"Nipocalimab's safety is estimated to be a 2. In clinical trials, Phase 2 means that there is some evidence of the drug's safety, but not yet any efficacy data."

Answered by AI

Could you please list any other times Nipocalimab has been studied in a clinical setting?

"Nipocalimab was first tested in 2019 at Impar Servicos Hospitalares S/A - Hospital Brasília. So far, there have been 18295 completed studies. Out of the 5 active clinical trials, a large number are taking place in Palm Springs, Florida."

Answered by AI

Have patients undergone this kind of treatment before?

"Nipocalimab is being trialed in 5 ongoing studies located in 33 countries and 103 cities. The first trial, which was completed in 2019, involved 111 patients and reached Phase 2 & 3 approval. To date, a total of 18295 clinical trials have been finished."

Answered by AI

Are recruitment efforts for this research project still underway?

"This study is no longer admitting patients. The listing was originally posted on January 15th, 2024 and was last updated on October 25th, 2022. There are currently 46 other trials for lupus nephritis and Nipocalimab that are open for recruitment."

Answered by AI

Who does this trial require as participants?

"This clinical trial is admitting 80 people, within the ages of 18 and 75 who currently have lupus nephritis. It is required that patients also meet the following criteria: Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III or IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening, Urine Protein to Creatinine Ratio (UPCR) greater than or equal to (>=) 1.0 milligram/milligram (mg"

Answered by AI

At how many hospitals is this clinical trial taking place?

"This clinical trial has 12 enrolling patients, which are Respire Research, LLC in Palm Springs, Omega Research Consultants in DeBary, and Reliant Medical Research in Miami. Other locations include 12 other sites."

Answered by AI

How many people are participating in this clinical trial?

"No, this study is no longer recruiting patients. The listing was first posted on January 15th, 2024 but the most recent update was on October 25th, 2022. If you are interested in participating in other trials, there are 41 lupus nephritis studies and 5 Nipocalimab investigations that are still looking for participants."

Answered by AI

Who else is applying?

What site did they apply to?
Next Innovative Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

How soon can I start?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I want to be in this trial because I want to learn more about this disease. I've had it since 2020 when I was diagnosed. But in August 2023 I had a flare up that put me in the hospital for a week. Then my doctor started me on Lasix to get the fluid out of my body. But I believe that this study will help me learn more about this disease.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
2026. "A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04883619.
All > Lupus Nephritis > Lupus
~53 spots leftby Feb 2028
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