Nipocalimab for Lupus Nephritis

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called nipocalimab (an anti-FcRn monoclonal antibody) to evaluate its effectiveness for individuals with active Lupus Nephritis, a kidney condition caused by lupus. Participants will receive either nipocalimab or a placebo, alongside standard medications. The trial targets individuals diagnosed with specific types of Lupus Nephritis within the last six months and who meet certain kidney test criteria. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nipocalimab has been tested in people for other conditions, yielding promising safety results. In studies involving patients with generalized myasthenia gravis (a condition that causes muscle weakness), nipocalimab was generally well-tolerated. Most side effects were mild to moderate, such as headaches or reactions at the injection site.

Since the current study is in an early phase, the researchers are still evaluating nipocalimab's safety for lupus nephritis. However, its testing in other conditions suggests a reasonable safety profile so far.

Prospective participants should discuss any concerns or questions with the study team or their healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about nipocalimab for lupus nephritis because it offers a novel approach to treatment. Unlike standard options like mycophenolate mofetil (MMF) or glucocorticoids, nipocalimab works by targeting and inhibiting the neonatal Fc receptor (FcRn). This mechanism reduces the levels of disease-causing antibodies in the blood, potentially improving kidney function more effectively. By offering a different method of action, nipocalimab could provide better outcomes for patients with lupus nephritis who might not respond well to existing therapies.

What evidence suggests that nipocalimab might be an effective treatment for Lupus Nephritis?

Research has shown that nipocalimab blocks a protein called FcRn, which helps lower harmful antibodies in the blood. These antibodies can mistakenly attack the body's own cells. This action shows promise for treating conditions like Lupus Nephritis (LN), where the immune system wrongly targets the kidneys. Early findings suggest that reducing these antibodies can decrease inflammation and improve kidney function in LN patients. Although detailed results in humans specifically for LN remain limited, similar treatments have shown promise in related autoimmune diseases. In this trial, participants will receive either a placebo or one of two doses of nipocalimab, alongside standard-of-care treatment, to evaluate its potential benefits for people with active Lupus Nephritis. ^{1 2 3 4 6}

Who Is on the Research Team?

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.

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 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?

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+

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

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04883619

NCT04883619 | A Study of Nipocalimab in Adult ... The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN). Detailed Description. LN ...

2. prod-globaltrialfinder.janssen.com prod-globaltrialfinder.janssen.com/trial/CR109008

A Study of Nipocalimab in Adult Participants With Active Lupus ... By targeting the IgG binding site on FcRn, nipocalimab is expected to block the binding and, hence, recycling of IgG into circulation, resulting ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-of-nipocalimab-in-adult-participants-with-active-lupus-nephritis

A Study of Nipocalimab in Adult Participants With Active Lupus ... The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

4. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2023/11/28008-Nipocalimab-for-Myasthenia-Gravis-V1.0-NOV2023-NON-CONF.pdf

Health Technology Briefing November 2023 By blocking IgG binding to FcRn, nipocalimab aims to increase the rate at which IgG autoantibodies are degraded, thereby reducing their levels ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04882878

NCT04882878 | A Study of Nipocalimab in Adult ... The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE). Detailed ...

6. jnjmedicalconnect.com jnjmedicalconnect.com/media/attestation/congresses/neuroscience/2024/mgfa/efficacy-and-safety-of-nipocalimab-in-patients-with-generalized-myasthenia-gravis-top-line-results.pdf

Efficacy and Safety of Nipocalimab in Patients with *Primary efficacy analysis dataset included patients from the safety analysis dataset who were antibody positive for a generalised Myasthenia ...