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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Felzartamab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires F.D.
    • CABA, Buenos Aires F.D., Argentina, C1431FWO
      • CEMIC
    • Caba, Buenos Aires F.D., Argentina, C1280AEB
      • Hospital Britanico de Buenos Aires
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5016
      • Clinica Priv Velez Sarsfield
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • Monash Health
    • Saint Albans, Victoria, Australia, 3021
      • Western Health
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital
  • Ontario
    • Toronto, Ontario, Canada, MST258
      • University Health Network - Toronto General Division
  • Quebec
    • Montreal, Quebec, Canada, H2X 3J4
      • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego (UCSD)
    • San Francisco, California, United States, 94143
      • University of California, San Francisco (UCSF)
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Georgia
    • Columbus, Georgia, United States, 31904
      • ClinCept, LLC/River City Vascular Specialists LLC
    • Lawrenceville, Georgia, United States, 30046
      • Georgia Nephrology - Lawrenceville
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Brooklyn, New York, United States, 11201
      • Joseph S. and Diane H. Steinberg Ambulatory Care Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University (OSU)
  • Texas
    • Grapevine, Texas, United States, 76051
      • Precision Comprehensive Clinical Research Solutions - Grapevine
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center
    • Katy, Texas, United States, 77450
      • R & H Clinical Research
    • Katy, Texas, United States, 77449
      • Accurate Clinical Research - Katy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Part 1

• 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)

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

Part 2

• Participants must complete Part 1 of the study to be eligible to participate in Part 2.

Exclusion Criteria:

Part 1

• 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

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 including cyclophosphamide, or biologic agents other than felzartamab
• Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) has been observed such that in the opinion of the investigator the participant will not benefit from continuing in Part 2 of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Felzartamab; Participants will receive two courses of multiple intravenous (IV) doses of felzartamab, separated by a 28-week off-treatment period. These courses are given in Part 1 and Part 2 of the trial.	Drug: Felzartamab; Administered IV; Other Names: MOR202; HIB202; MOR03087; TJ202; BIIB148

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	Up to Week 104

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)	Baseline, Up to Week 104
Proportion of Participants Who Achieve a Complete Renal Response (CRR)	Week 24
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (PRR: CRR+PRR)	Week 24
Change from Baseline in Serum Creatinine	Baseline, Up to Week 104
Change from Baseline in Urine Protein	Baseline, Up to Week 104
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)	Baseline, Up to Week 104
Change from Baseline in eGFR Slope	Baseline, Up to Week 104
Change from Baseline in Lupus Serologic Markers	Baseline, Up to Week 104
Felzartamab Serum Concentrations	Up to Week 104
Number of Participants with Anti-drug Antibodies to Felzartamab	Baseline, Up to Week 104

Collaborators and Investigators

• Sponsor: HI-Bio, A Biogen Company
• Investigators: Study Director: Medical Director, HI-Bio, A Biogen Company

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lupus; Systemic Lupus Erythematosus; LN; Felzartamab; Refractory LN
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Nephritis; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; felzartamab
• Other Study ID Numbers: 299LE101; HIB-202-101 (Other Identifier: Human Immunology Biosciences (HI-Bio))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No