A Study of Felzartamab in Participants With Lupus Nephritis

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).

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

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: Felzartamab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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 Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Felzartamab<br> | Drug: Felzartamab<br>* Specified dose on specified days<br>* Other names: HIB202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Urine Protein:Creatinine Ratio (UPCR) |  | Baseline, Up to 12 months | 
| Proportion of Participants Who Achieve a Complete Renal Response (CRR) |  | Month 6 | 
| Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (CRR+PRR) |  | Up to 12 months | 
| Change from Baseline in Serum Creatinine |  | Baseline, Up to 12 months | 
| Change from Baseline in Urine Protein |  | Baseline, Up to 12 months | 
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) |  | Baseline, Up to 12 months | 
| Change from Baseline in eGFR Slope |  | Baseline, Up to 12 months | 
| Change from Baseline in Lupus Serologic Markers |  | Baseline, Up to 12 months | 
| Felzartamab Serum Concentrations |  | Up to 12 months | 
| Number of Participants with Anti-drug Antibodies to Felzartamab |  | Baseline, Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, Refractory LN, Felzartamab, LN, Systemic Lupus Erythematosus