A Study of Felzartamab in Participants With Lupus Nephritis

April 7, 2024 updated by: HI-Bio

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Caba, Argentina, C1280AEB
        • Recruiting
        • HI-Bio Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • HI-Bio Investigational Site
      • Stanford, California, United States, 94305
        • Recruiting
        • HI-Bio Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • HI-Bio Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • HI-Bio Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Recruiting
        • HI-Bio Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • HI-Bio Investigational Site
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • HI-Bio Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HI-Bio

Investigators

  • Study Director: HI-Bio Clinical Program Lead, HI-Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIB-202-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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