A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

Last updated: May 12, 2025
Sponsor: HI-Bio, A Biogen Company
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

Felzartamab

Clinical Study ID

NCT06064929
299LE101
HIB-202-101
  • Ages 18-75
  • All Genders

Study Summary

In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN. In people with LN, antibodies build up in the glomeruli of the kidneys. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are small filters that remove waste and extra fluid from the blood. This buildup leads to inflammation and damage to the kidneys.

Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with LN. Symptoms of LN can include fever, swelling in the legs and body, and high blood pressure. If left untreated, LN can eventually lead to kidney failure.

In this study, researchers will learn more about how a study drug called felzartamab affects people with LN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to learn more about the safety of felzartamab and how it works in the body of people with LN who are taking standard of care. This will help researchers decide if they should do more studies with felzartamab in people with LN. Standard of care is the usual treatment or care given to patients for a disease, as prescribed by their doctor.

The main question researchers want to answer in this study are:

• How many participants had adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug. It can happen during a clinical study or within a certain amount of time after the study has ended.

Researchers will also learn more about:

  • How much felzartamab affects proteinuria and the level of creatinine in the urine. Creatinine is a protein that is released into the blood from normal muscle wear and tear. Its levels can help doctors understand how well your kidneys are working.

  • How many participants have a complete response. A complete response means that their urine protein levels decrease to a low level, and their kidney function stays stable.

  • How many participants have a 50% decrease in the level of protein and creatinine in their urine.

  • How much felzartamab affects the participants' lupus-related blood tests.

  • How the body processes felzartamab.

  • How many participants develop antibodies against felzartamab in the blood.

This study will be done as follows:

  • Participants will be screened to check if they can join the study. The screening period will be up to 42 days.

  • Throughout the study, all participants will continue taking their standard of care, as prescribed by their doctor.

  • There are 2 parts in this study. In both parts, participants will receive felzartamab through an intravenous infusion, also known as an IV. This means it is being given into a vein.

  • In Part 1, participants will have up to 14 visits to their study research center. In Part 2, participants may have up to 15 visits.

  • Each participant will be in the study for about 2 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Part 1

  • Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 EuropeanLeague 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 priorto 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 bythe Chronic Kidney Disease Epidemiology Collaboration formula)

  1. If eGFR is ≥35 to <45 mL/min/1.73m^2, renal biopsy must be within 6 months ofscreening and must not have >50% of glomeruli with sclerosis. If the renalbiopsy was performed more than 6 months prior to screening, a repeat biopsymust be done during screening after all the other eligibility criteria are met

  2. If eGFR is ≥45 mL/min/1.73 m^2, renal biopsy must be within 1 year prior toscreening. If the renal biopsy was performed more than 1 year prior toscreening, a repeat biopsy must be done during screening after all the othereligibility criteria are met

  • History of inadequate response, for lack of efficacy or intolerance, to at least athree-month course of one standard of care treatment for lupus nephritis, asdetermined by the treating physician

Part 2

  • Participants must complete Part 1 of the study to be eligible to participate in Part

Exclusion

Exclusion Criteria:

Part 1

  • Presence of rapidly progressive glomerulonephritis, as defined by at least one ofthe following: crescent formation in > 50% of glomeruli on renal biopsy, sustaineddoubling of serum creatinine within 12 weeks of screening, or the investigator'sopinion 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 requiredialysis during the study treatment period

  • A previous kidney transplant or other organ transplant, or planned transplant withinstudy treatment period

Part 2

  • Did not complete Part 1 of the study

  • Received protocol-prohibited medications in Part 1 such as calcineurin inhibitors (e.g., cyclosporine, tacrolimus, or voclosporin), alkylating agents includingcyclophosphamide, or biologic agents other than felzartamab

  • Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) hasbeen observed such that in the opinion of the investigator the participant will notbenefit from continuing in Part 2 of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Felzartamab
Phase: 1/2
Study Start date:
November 01, 2023
Estimated Completion Date:
June 01, 2026

Study Description

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Connect with a study center

  • Hospital Britanico de Buenos Aires

    Caba, Capital Federal C1280AEB
    Argentina

    Active - Recruiting

  • CEMIC

    Caba, Ciudad Autonoma De Buenos Aires C1431FWO
    Argentina

    Active - Recruiting

  • Clinica Priv Velez Sarsfield

    Córdoba, Cordoba X5016
    Argentina

    Active - Recruiting

  • HI-Bio Investigational Site

    Córdoba, Cordoba X5016
    Argentina

    Active - Recruiting

  • HI-Bio Investigational Site

    Caba, C1431FWO
    Argentina

    Active - Recruiting

  • HI-Bio Investigational Site

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • HI-Bio Investigational Site

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • HI-Bio Investigational Site

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health

    Melbourne, Victoria 3168
    Australia

    Active - Recruiting

  • HI-Bio Investigational Site

    Saint Albans, Victoria 3021
    Australia

    Active - Recruiting

  • Western Health

    Saint Albans, Victoria 3021
    Australia

    Active - Recruiting

  • HI-Bio Investigational Site

    Vancouver, British Columbia V6Z1Y6
    Canada

    Site Not Available

  • St. Paul's Hospital

    Vancouver, British Columbia V6Z1Y6
    Canada

    Active - Recruiting

  • HI-Bio Investigational Site

    Toronto, Ontario MST258
    Canada

    Site Not Available

  • University Health Network - Toronto General Division

    Toronto, Ontario MST258
    Canada

    Active - Recruiting

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

    Montréal, Quebec H2X 3J4
    Canada

    Active - Recruiting

  • HI-Bio Investigational Site

    Montréal, Quebec H2X 3J4
    Canada

    Active - Recruiting

  • Centro Integral en Reumatología S.A. de C.V.

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • HI-Bio Investigational Site

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Ciudad de Mexico, Mexico City 14080
    Mexico

    Site Not Available

  • HI-Bio Investigational Site

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • Medical Care and Research S.A de C.V.

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • HI-Bio Investigational Site

    Chihuahua, 31210
    Mexico

    Site Not Available

  • Servicios Avanzados de Investigación Médica/ Mediadvance Clinical S.C.

    Chihuahua, 31210
    Mexico

    Site Not Available

  • HI-Bio Investigational Site

    Mexico City, 14080
    Mexico

    Site Not Available

  • Centricity Research - Phoenix

    Mesa, Arizona 85206
    United States

    Site Not Available

  • HI-Bio Investigational Site

    Mesa, Arizona 85206
    United States

    Site Not Available

  • HI-Bio Investigational Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of California, San Diego (UCSD)

    La Jolla, California 92037
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    San Francisco, California 94143
    United States

    Site Not Available

  • University of California, San Francisco (UCSF)

    San Francisco, California 94143
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Stanford, California 94305
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Active - Recruiting

  • ClinCept, LLC/River City Vascular Specialists LLC

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Georgia Nephrology - Lawrenceville

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York 11201
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • The Ohio State University (OSU)

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • HI-Bio Investigational Site

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • R & H Clinical Research

    Katy, Texas 77450
    United States

    Active - Recruiting

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