Felzartamab infusions for adults with primary membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3, randomized interventional trial, adults with primary membranous nephropathy and nephrotic-range proteinuria will receive either felzartamab infusions or tacrolimus alongside standard-of-care immunosuppression. The primary endpoint is the rate of complete remission of proteinuria, with secondary endpoints including additional clinical remission measures, changes in serum anti-PLA2R antibody levels, patient-reported outcomes, and safety, pharmacokinetics, and immunogenicity. Diagnosis must be confirmed by kidney biopsy or positive anti-PLA2R antibody testing according to protocol requirements. Participants will be followed at multiple timepoints to compare efficacy and adverse events between treatment arms.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Diagnosed with PMN in need of IST according to the Investigator's clinical judgment. The diagnosis of PMN must be documented with the presence of nephrotic syndrome, and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or within 5 years of signing the informed consent form (ICF) \[see kidney biopsy exception below for participants positive for anti-PLA2R antibodies\]. For these participants, the biopsy report with redacted protected health information must be available to be reviewed by the Sponsor or an independent nephropathologist. If the participant requires a kidney biopsy during Screening, medical monitor approval must be obtained, and all other eligibility criteria should be reviewed to ensure that the participant is otherwise eligible prior to performing the kidney biopsy.

  a. Kidney biopsy exception for anti-PLA2R antibody positive participants: Participants who are positive for anti-PLA2R antibodies at Screening and have not had a kidney biopsy performed within 5 years of signing the ICF may be eligible for the study without undergoing a kidney biopsy based on medical monitor review of screening tests confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer ≥ 20 RU/mL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes.
* Meets one of the following:

  1. Newly diagnosed PMN, defined as having never received IST for PMN in the past.
  2. Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of nephrotic range proteinuria (urine protein to creatinine ratio \[UPCR\] ≥ 3.0 gram per gram \[g/g\] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour \[g/24 h\]).
* Participants must be on the maximally approved dose or maximally tolerated dose of at least one renin-angiotensin-aldosterone system (RAAS) inhibition therapy (e.g. angiotensin-converting enzyme inhibitor \[ACEI\], angiotensin receptor blocker \[ARB\], and/or mineralocorticoid receptor antagonists \[MRA\]) for at least 4 weeks prior to Screening. Participants not on the maximally approved dose of RAAS inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). Participants on MRA therapy alone at Screening must have documented prior intolerance of ACEI or ARB therapy. Participants who do not tolerate ACEI or ARB therapy are not required to start MRA therapy prior to Screening.
* A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 4 weeks prior to signing the ICF.

Key Exclusion Criteria:

* Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \[SLE\], hepatitis B, hepatitis C, etc).
* Severe renal impairment is defined as an eGFR ≤ 30 mL/min/1.73m\^2 at Screening or including the need for dialysis or renal replacement therapy.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it's running

• Apogee Clinical Research, LLC
  Huntsville, Alabama, United States Recruiting
• The Nephrology Group, Inc. - Fresno
  Fresno, California, United States Recruiting
• Academic Medical Research Institute
  Los Angeles, California, United States Recruiting
• UCLA Health Connie Frank Kidney Transplant Center and General Nephrology
  Los Angeles, California, United States Recruiting
• UCSF Medical Center
  San Francisco, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting

+67 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.