Clinical trial NCT06064929: A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
Official title: An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lupus Nephritis
Keywords: Felzartamab
LN
Systemic Lupus Erythematosus
Lupus
Refractory LN
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to Week 104
Secondary outcomes:
measure: Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
timeFrame: Baseline, Up to Week 104
measure: Proportion of Participants Who Achieve a Complete Renal Response (CRR)
timeFrame: Week 24
measure: Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (PRR: CRR+PRR)
timeFrame: Week 24
measure: Change from Baseline in Serum Creatinine
timeFrame: Baseline, Up to Week 104
measure: Change from Baseline in Urine Protein
timeFrame: Baseline, Up to Week 104
measure: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, Up to Week 104
measure: Change from Baseline in eGFR Slope
timeFrame: Baseline, Up to Week 104
measure: Change from Baseline in Lupus Serologic Markers
timeFrame: Baseline, Up to Week 104
measure: Felzartamab Serum Concentrations
timeFrame: Up to Week 104
measure: Number of Participants with Anti-drug Antibodies to Felzartamab
timeFrame: Baseline, Up to Week 104
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Centricity Research - Phoenix
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Columbus
country: United States
facility: ClinCept, LLC/River City Vascular Specialists LLC
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Nephrology - Lawrenceville
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Brooklyn
country: United States
facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University (OSU)
state: Ohio
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Katy
country: United States
facility: Accurate Clinical Research - Katy
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Capital Federal
city: Caba
country: Argentina
facility: CEMIC
state: Ciudad Autonoma De Buenos Aires
city: Córdoba
country: Argentina
facility: Clinica Priv Velez Sarsfield
state: Cordoba
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Monash Health
state: Victoria
city: Saint Albans
country: Australia
facility: Western Health
state: Victoria
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network - Toronto General Division
state: Ontario
city: Montréal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
state: Quebec
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatología S.A. de C.V.
state: Jalisco
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Mexico City
city: Mérida
country: Mexico
facility: Medical Care and Research S.A de C.V.
state: Yucatan
city: Chihuahua
country: Mexico
facility: Servicios Avanzados de Investigación Médica/ Mediadvance Clinical S.C.
Study officials:
affiliation: HI-Bio, A Biogen Company
name: Medical Director
role: STUDY_DIRECTOR
References: