A Study of Felzartamab in Participants With Lupus Nephritis

Last updated: April 7, 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

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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)

  • 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

Exclusion

Exclusion Criteria:

  • 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

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 11203
    United States

    Active - Recruiting

  • 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

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