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Exploring the effects of felzartamab in adults with lupus nephritis

An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis

Phase1; Phase2 Interventional Biogen · NCT06064929

This study tests if a new treatment called felzartamab can help adults with lupus nephritis by targeting harmful immune cells to improve kidney health.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment20 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiogen Industry-sponsored
Drugs / interventionsfelzartamab, cyclophosphamide
Locations27 sites (Mesa, Arizona and 26 other locations)
Trial IDNCT06064929 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effects of felzartamab, a monoclonal antibody, in adults aged 18 to 75 with active lupus nephritis. Researchers aim to understand how this treatment can target immune cells that produce harmful antibodies, which contribute to kidney inflammation and damage. Participants will be monitored for changes in protein levels in urine and overall kidney function. The study includes both Phase 1 and Phase 2 assessments to evaluate the drug's efficacy and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with systemic lupus erythematosus and class III or IV lupus nephritis.

Not a fit: Patients with severe kidney damage or those not meeting the specific diagnostic criteria for lupus nephritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney health and quality of life for patients with lupus nephritis.

How similar studies have performed: Previous studies involving monoclonal antibodies for lupus nephritis have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Part 1

* Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria
* Diagnosis of International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 1 year prior to or during screening, either with or without the presence of Class V LN
* Proteinuria (urine protein to creatinine ratio) \> 1.0 gram per gram (g/g), based on 24-hour urine collection during screening
* eGFR ≥ 45 milliliter/minute/1.73 square meters (mL/min/1.73 m\^2) (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)

  1. If eGFR is ≥35 to \<45 mL/min/1.73m\^2, renal biopsy must be within 6 months of screening and must not have \>50% of glomeruli with sclerosis. If the renal biopsy was performed more than 6 months prior to screening, a repeat biopsy must be done during screening after all the other eligibility criteria are met
  2. If eGFR is ≥45 mL/min/1.73 m\^2, renal biopsy must be within 1 year prior to screening. If the renal biopsy was performed more than 1 year prior to screening, a repeat biopsy must be done during screening after all the other eligibility criteria are met
* History of inadequate response, for lack of efficacy or intolerance, to at least a three-month course of one standard of care treatment for lupus nephritis, as determined by the treating physician

Part 2

* Participants must complete Part 1 of the study to be eligible to participate in Part 2.

Exclusion Criteria:

Part 1

* Presence of rapidly progressive glomerulonephritis, as defined by at least one of the following: crescent formation in \> 50% of glomeruli on renal biopsy, sustained doubling of serum creatinine within 12 weeks of screening, or the investigator's opinion that the participant has rapidly progressive glomerulonephritis
* Greater than 50% of glomeruli with sclerosis on renal biopsy
* Currently requiring hemodialysis or peritoneal dialysis or expected to require dialysis during the study treatment period
* A previous kidney transplant or other organ transplant, or planned transplant within study treatment period

Part 2

* Did not complete Part 1 of the study
* Received protocol-prohibited medications in Part 1 such as calcineurin inhibitors (e.g., cyclosporine, tacrolimus, or voclosporin), alkylating agents including cyclophosphamide, or biologic agents other than felzartamab
* Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) has been observed such that in the opinion of the investigator the participant will not benefit from continuing in Part 2 of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Mesa, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus NephritisFelzartamabLNSystemic Lupus ErythematosusLupusRefractory LN
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.