A Study of Felzartamab in Participants With Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064929
• Other study ID #: HIB-202-101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: HI-Bio
• Contact: HI-Bio Clinical Program Lead
• Phone: 1-408-548-7261
• Email: clinicaltrialdisclosure[@]hibio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Felzartamab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	HI-Bio Investigational Site	Caba
Australia	HI-Bio Investigational Site	Westmead	New South Wales
United States	HI-Bio Investigational Site	Ann Arbor	Michigan
United States	HI-Bio Investigational Site	Brooklyn	New York
United States	HI-Bio Investigational Site	Columbus	Ohio
United States	HI-Bio Investigational Site	Columbus	Georgia
United States	HI-Bio Investigational Site	Houston	Texas
United States	HI-Bio Investigational Site	La Jolla	California
United States	HI-Bio Investigational Site	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
HI-Bio

Countries where clinical trial is conducted

United States,  Argentina,  Australia, 

Outcome

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