Felzartamab for Membranous Nephropathy

(PROMINENT Trial)

Recruiting at 1 trial location

Overseen By US Biogen Clinical Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Biogen

Must be taking: ACEI or ARB

Disqualifiers: Secondary MN, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 35

180 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease. The main question that researchers want to answer is: * How many participants achieve a complete response after 104 weeks of treatment? * A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable. Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * How many participants develop antibodies against felzartamab in the blood? * How many participants achieve a complete response after 76 weeks of treatment * How many participants have medical problems during the study * How felzartamab is processed by the body * How felzartamab affects participants' tiredness and overall physical health The study will be done as follows: * Participants will be screened to check if they can join the study. This may take up to 42 days. * Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets. * If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment. * If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104. * In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

Adults with primary membranous nephropathy (PMN) who have high levels of protein in their urine despite receiving supportive care for at least 3 months. This includes those newly diagnosed or those who relapsed after treatment. Participants must be on the highest dose they can tolerate of specific blood pressure medications and need immune system therapy as judged by a doctor.

Inclusion Criteria

I have PMN, need treatment, and my diagnosis was confirmed by a kidney biopsy or positive anti-PLA2R antibodies.

I have positive anti-PLA2R antibodies and haven't had a kidney biopsy in the last 5 years.

I have never received immune system therapy for my newly diagnosed condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Open-Label Treatment

Participants receive either felzartamab as intravenous infusions or tacrolimus orally

104 weeks

Up to 23 visits

Non-Responder Treatment

Participants who meet rescue criteria may receive regional standard of care immunosuppressive therapy or additional doses of felzartamab

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 52 weeks

Follow-up visits every 12 weeks until Week 104

Treatment Details

Interventions

• Felzartamab

Trial Overview The study is testing felzartamab, a lab-made antibody designed to target immune cells causing kidney damage in PMN, against tacrolimus, an existing drug for PMN. Researchers will compare effects on urine protein levels and kidney function over 104 weeks, with some participants potentially followed up to 156 weeks if needed.

Participant Groups

Group I: Open-Label Treatment Phase Experimental Treatment 2 Interventions

Participants will receive several intravenous (IV) doses of felzartamab or oral tacrolimus in the Open-Label Treatment Phase.

Group II: Non-Responder Treatment Phase Experimental Treatment 2 Interventions

Participants initially randomized to felzartamab or tacrolimus who meet rescue criteria may receive regional standard of care immunosuppressive therapy (IST) per Investigator discretion or several IV doses of felzartamab, respectively, in the Non-Responder Treatment Phase.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada