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New antibody drug targets kidney damage in lupus patients

NCT ID NCT06064929

Disease control Sponsor: HI-Bio, A Biogen Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This early-stage study tests a drug called felzartamab in 14 people with active lupus nephritis, a kidney condition caused by lupus. The drug is a lab-made antibody designed to lower harmful antibody buildup in the kidneys. The main goal is to check safety and how the drug works in the body, while all participants continue their usual treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
felzartamab (a lab-made antibody given by IV)
What this could lead to
If it works, this could point toward a new treatment option for lupus nephritis that helps reduce kidney damage.
What could go wrong
This is a very early, small Phase 1b trial with only 14 people, so results may not apply to everyone. The main goal is safety, not yet proof of effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

Contacts and locations

Locations

  • Accurate Clinical Research - Katy

    Katy, Texas, 77449, United States

  • CEMIC

    CABA, Buenos Aires F.D., C1431FWO, Argentina

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

    Montreal, Quebec, H2X 3J4, Canada

  • ClinCept, LLC/River City Vascular Specialists LLC

    Columbus, Georgia, 31904, United States

  • Clinica Priv Velez Sarsfield

    Córdoba, Córdoba Province, X5016, Argentina

  • Georgia Nephrology - Lawrenceville

    Lawrenceville, Georgia, 30046, United States

  • Hospital Britanico de Buenos Aires

    Caba, Buenos Aires F.D., C1280AEB, Argentina

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York, 11201, United States

  • Monash Health

    Melbourne, Victoria, 3168, Australia

  • Precision Comprehensive Clinical Research Solutions - Grapevine

    Grapevine, Texas, 76051, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • R & H Clinical Research

    Katy, Texas, 77450, United States

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203, United States

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • The Ohio State University (OSU)

    Columbus, Ohio, 43210, United States

  • University Health Network - Toronto General Division

    Toronto, Ontario, MST258, Canada

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California, San Diego (UCSD)

    La Jolla, California, 92037, United States

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94143, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Western Health

    Saint Albans, Victoria, 3021, Australia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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