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A Study of Felzartamab in Participants With Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Felzartamab
Sponsored by
HI-Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Felzartamab, LN, Systemic Lupus Erythematosus, Lupus, Refractory LN

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • HI-Bio Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Felzartamab

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events

Secondary Outcome Measures

Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
Proportion of Participants Who Achieve a Complete Renal Response (CRR)
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (CRR+PRR)
Change from Baseline in Serum Creatinine
Change from Baseline in Urine Protein
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline in eGFR Slope
Change from Baseline in Lupus Serologic Markers
Felzartamab Serum Concentrations
Number of Participants with Anti-drug Antibodies to Felzartamab

Full Information

First Posted
September 26, 2023
Last Updated
October 23, 2023
Sponsor
HI-Bio
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1. Study Identification

Unique Protocol Identification Number
NCT06064929
Brief Title
A Study of Felzartamab in Participants With Lupus Nephritis
Official Title
An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HI-Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Felzartamab, LN, Systemic Lupus Erythematosus, Lupus, Refractory LN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Felzartamab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Felzartamab
Other Intervention Name(s)
HIB202
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
Time Frame
Baseline, Up to 12 months
Title
Proportion of Participants Who Achieve a Complete Renal Response (CRR)
Time Frame
Month 6
Title
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (CRR+PRR)
Time Frame
Up to 12 months
Title
Change from Baseline in Serum Creatinine
Time Frame
Baseline, Up to 12 months
Title
Change from Baseline in Urine Protein
Time Frame
Baseline, Up to 12 months
Title
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame
Baseline, Up to 12 months
Title
Change from Baseline in eGFR Slope
Time Frame
Baseline, Up to 12 months
Title
Change from Baseline in Lupus Serologic Markers
Time Frame
Baseline, Up to 12 months
Title
Felzartamab Serum Concentrations
Time Frame
Up to 12 months
Title
Number of Participants with Anti-drug Antibodies to Felzartamab
Time Frame
Baseline, Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HI-Bio Clinical Program Lead
Phone
1-408-548-7261
Email
clinicaltrialdisclosure@hibio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HI-Bio Clinical Program Lead
Organizational Affiliation
HI-Bio
Official's Role
Study Director
Facility Information:
Facility Name
HI-Bio Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data supporting this study are not publicly available due to the ongoing nature of the clinical development program. Datasets may be available upon reasonable request 18 months after the final clinical study report has been completed and, as appropriate, once the regulatory review of the indication or drug has completed, whichever is later.

Learn more about this trial

A Study of Felzartamab in Participants With Lupus Nephritis

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