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

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.

Conditions

• Lupus Nephritis

Interventions

DRUG

Felzartamab

Administered IV

Sponsors & Collaborators

• HI-Bio, A Biogen Company

  lead INDUSTRY

Principal Investigators

• Medical Director · HI-Bio, A Biogen Company

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Canada

Study Locations