A Study of Felzartamab in Participants With Lupus Nephritis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06064929
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

HI-Bio, A Biogen Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation HI-Bio, A Biogen Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Canada, Mexico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis
Additional Details

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

Arms & Interventions

Arms

Experimental: Felzartamab

Interventions

Drug: - Felzartamab

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Centricity Research - Phoenix, Mesa, Arizona

Status

Withdrawn

Address

Centricity Research - Phoenix

Mesa, Arizona, 85206

La Jolla, California

Status

Recruiting

Address

University of California, San Diego (UCSD)

La Jolla, California, 92037

San Francisco, California

Status

Recruiting

Address

University of California, San Francisco (UCSF)

San Francisco, California, 94143

Stanford University Medical Center, Stanford, California

Status

Recruiting

Address

Stanford University Medical Center

Stanford, California, 94305

Columbus, Georgia

Status

Recruiting

Address

ClinCept, LLC/River City Vascular Specialists LLC

Columbus, Georgia, 31904

Georgia Nephrology - Lawrenceville, Lawrenceville, Georgia

Status

Recruiting

Address

Georgia Nephrology - Lawrenceville

Lawrenceville, Georgia, 30046

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Brooklyn, New York

Status

Not yet recruiting

Address

Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn, New York, 11201

SUNY Downstate Medical Center, Brooklyn, New York

Status

Recruiting

Address

SUNY Downstate Medical Center

Brooklyn, New York, 11203

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

The Ohio State University (OSU), Columbus, Ohio

Status

Recruiting

Address

The Ohio State University (OSU)

Columbus, Ohio, 43210

Prolato Clinical Research Center, Houston, Texas

Status

Recruiting

Address

Prolato Clinical Research Center

Houston, Texas, 77054

International Sites

Hospital Britanico de Buenos Aires, Caba, Capital Federal, Argentina

Status

Recruiting

Address

Hospital Britanico de Buenos Aires

Caba, Capital Federal, C1280AEB

CEMIC, Caba, Ciudad Autonoma De Buenos Aires, Argentina

Status

Recruiting

Address

CEMIC

Caba, Ciudad Autonoma De Buenos Aires, C1431FWO

Clinica Priv Velez Sarsfield, Córdoba, Cordoba, Argentina

Status

Recruiting

Address

Clinica Priv Velez Sarsfield

Córdoba, Cordoba, X5016

Westmead Hospital, Westmead, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, New South Wales, 2145

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102

Monash Health, Melbourne, Victoria, Australia

Status

Recruiting

Address

Monash Health

Melbourne, Victoria, 3168

Western Health, Saint Albans, Victoria, Australia

Status

Recruiting

Address

Western Health

Saint Albans, Victoria, 3021

St. Paul's Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network - Toronto General Division

Toronto, Ontario, MST258

Montréal, Quebec, Canada

Status

Recruiting

Address

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

Montréal, Quebec, H2X 3J4

Guadalajara, Jalisco, Mexico

Status

Not yet recruiting

Address

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

Guadalajara, Jalisco, 44160

Ciudad de Mexico, Mexico City, Mexico

Status

Not yet recruiting

Address

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Ciudad de Mexico, Mexico City, 14080

Medical Care and Research S.A de C.V., Mérida, Yucatan, Mexico

Status

Not yet recruiting

Address

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

Mérida, Yucatan, 97070

Chihuahua, Mexico

Status

Not yet recruiting

Address

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

Chihuahua, , 31210