Nipocalimab for Lupus Nephritis

Recruiting at 77 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must be taking: Prednisone, ACE inhibitors

Must not be taking: Cyclophosphamide

Disqualifiers: Asthma, RA, Crohn's, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

80 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Group 3: Nipocalimab Dose 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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: Placebo Placebo Group 2 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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

References

1. England pubmed.ncbi.nlm.nih.gov

Targeted IgA Fc receptor I (FcαRI) therapy in the early intervention and treatment of pristane-induced lupus nephritis in mice. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Increased expression of FcgammaRI/CD64 on circulating monocytes parallels ongoing inflammation and nephritis in lupus. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of lupus-prone NZB/NZW F1 mice with recombinant soluble Fc gamma receptor II (CD32). [2008]

4. United States pubmed.ncbi.nlm.nih.gov

The Fcgamma receptor IIIA-158F allele is a major risk factor for the development of lupus nephritis among Caucasians but not non-Caucasians. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Low-binding alleles of Fcgamma receptor types IIA and IIIA are inherited independently and are associated with systemic lupus erythematosus in Hispanic patients. [2021]