A Study of Felzartamab in Participants With Lupus Nephritis

Sponsor

HI-Bio (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06064929

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: Felzartamab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Felzartamab	Drug: Felzartamab Specified dose on specified days Other Names: HIB202

Arm

Intervention/Treatment

Experimental: Felzartamab

Drug: Felzartamab

Specified dose on specified days

Other Names:

HIB202

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events [Up to 12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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