80 Participants Needed

Nipocalimab for Lupus Nephritis

Recruiting at 77 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
Must be taking: Prednisone, ACE inhibitors
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of prednisone and, if applicable, a stable dose of ACE inhibitors or ARBs for at least 2 weeks before starting the study.

How is the drug Nipocalimab unique for treating lupus nephritis?

Nipocalimab is unique because it is an anti-FcRn monoclonal antibody that works by blocking the recycling of antibodies, potentially reducing harmful immune responses in lupus nephritis. This mechanism is different from traditional treatments that often focus on suppressing the immune system more broadly.12345

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am up-to-date with my vaccinations, including COVID-19, as per local guidelines.
Your urine test shows a high level of protein compared to creatinine, measured twice during screening.
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.
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Exclusion Criteria

I have taken oral cyclophosphamide in the last 3 months or IV cyclophosphamide in the last 6 months.
I have had COVID-19 or been in close contact with someone who has in the last 6 weeks.
I've needed steroids 3+ times in the last year for conditions other than Lupus Nephritis.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 8 weeks

Treatment

Participants receive either nipocalimab or placebo intravenously every two weeks along with standard-of-care treatment

52 weeks
Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Long-term extension (optional)

Participants who achieve complete renal response may opt into continuation of treatment until unblinding of the study

What Are the Treatments Tested in This Trial?

Interventions

  • Nipocalimab
  • Placebo
  • Standard-of-care treatment
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions
Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions
Group III: Group 1: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

Targeted IgA Fc receptor I (FcαRI) therapy in the early intervention and treatment of pristane-induced lupus nephritis in mice. [2018]
Increased expression of FcgammaRI/CD64 on circulating monocytes parallels ongoing inflammation and nephritis in lupus. [2021]
Treatment of lupus-prone NZB/NZW F1 mice with recombinant soluble Fc gamma receptor II (CD32). [2008]
The Fcgamma receptor IIIA-158F allele is a major risk factor for the development of lupus nephritis among Caucasians but not non-Caucasians. [2022]
Low-binding alleles of Fcgamma receptor types IIA and IIIA are inherited independently and are associated with systemic lupus erythematosus in Hispanic patients. [2021]
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