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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT06064929

Public ClinicalTrials.gov record NCT06064929. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 5:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06064929
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
HI-Bio, A Biogen Company
Industry
Enrollment
14 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2023
Primary completion
Jun 23, 2026
Completion
Jul 7, 2026
Last update posted
Jul 16, 2026

2023 – 2026

United States locations

U.S. sites
14
U.S. states
6
U.S. cities
12
Facility City State ZIP Site status
University of California, San Diego (UCSD) La Jolla California 92037
University of California, San Francisco (UCSF) San Francisco California 94143
Stanford University Medical Center Stanford California 94305
ClinCept, LLC/River City Vascular Specialists LLC Columbus Georgia 31904
Georgia Nephrology - Lawrenceville Lawrenceville Georgia 30046
University of Michigan Ann Arbor Michigan 48109
Joseph S. and Diane H. Steinberg Ambulatory Care Center Brooklyn New York 11201
SUNY Downstate Medical Center Brooklyn New York 11203
University Hospitals Cleveland Medical Center Cleveland Ohio 44106
The Ohio State University (OSU) Columbus Ohio 43210
Precision Comprehensive Clinical Research Solutions - Grapevine Grapevine Texas 76051
Prolato Clinical Research Center Houston Texas 77054
Accurate Clinical Research - Katy Katy Texas 77449
R & H Clinical Research Katy Texas 77450

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06064929, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06064929 live on ClinicalTrials.gov.

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