A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Conditions

• Primary Membranous Nephropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Felzartamab — DRUG
  Administered intravenously
• Tacrolimus — DRUG
  Administered orally
• Standard of Care IST — DRUG
  Administered intravenously and orally

Study Details

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.

Key Dates

Start date

May 22, 2025

Status verified

Jun 2026

Primary completion

Dec 29, 2028

Completion

Mar 29, 2029

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Percentage of Participants who Achieve Complete Remission (CR) at Week 104 [ Time Frame: Week 104 ]

Central Contacts

• US Biogen Clinical Trial Center
  866-633-4636
  [email protected]
• Global Biogen Clinical Trial Center
  [email protected]

Locations (15)

Find similar trials in Huntsville, AL

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