Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis

June 16, 2026 updated by: Regeneron Pharmaceuticals

A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis

This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).

The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.

This is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) Bordeaux
  • Germany
      • Mainz, Germany, 55131
        • Recruiting
        • University Medical Center of the Johannes Gutenberg-University Mainz
    • Bavaria
      • Regensburg, Bavaria, Germany, D-93053
        • Recruiting
        • University Hospital Regensburg
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, South Korea, 14068
        • Recruiting
        • Hallym University Sacred Heart Hospital
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Gregorio Marañon
      • Málaga, Spain, 290090
        • Recruiting
        • Hospital Regional Universitario de Malaga
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung General Veterans Hospital
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Hospital
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Key General Inclusion Criteria:

  1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
  2. Participant must have refractory or relapsed disease, as described in the protocol

Key General Exclusion Criteria:

  1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
  2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
  3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm 1: Vonsetamig
Drug: Vonsetamig
Administered as per the protocol
Other Names:
  • REGN5459
Experimental: Experimental Arm 2: Odronextamab
Drug: Odronextamab
Administered as per the protocol
Other Names:
  • REGN1979

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurrence of Dose Limiting Toxicities (DLT)
Time Frame: Up to 56 days
Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Through week 76
Through week 76
Severity of TEAEs
Time Frame: Through week 76
Through week 76

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative total exposure to corticosteroids
Time Frame: At 76 weeks
At 76 weeks
Absolute values of urine Protein-Creatinine Ratio (uPCR)
Time Frame: Through week 76
Through week 76
Percent change from baseline of uPCR
Time Frame: Through week 76
Through week 76
Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine
Time Frame: Through week 76
Through week 76
Percent change from baseline of eGFR serum creatinine
Time Frame: Through week 76
Through week 76
Absolute values of blood B-cell counts and other immune cell populations
Time Frame: Through week 76
T cells and Natural Killer (NK) cells
Through week 76
Change from baseline of blood B-cell counts and other immune cell populations
Time Frame: Through week 76
T cells and NK cells
Through week 76
Absolute values of double-stranded DNA (dsDNA) antibodies
Time Frame: Through week 76
Through week 76
Percent change from baseline of dsDNA antibodies
Time Frame: Through week 76
Through week 76
Absolute values of anti-Smith antibodies
Time Frame: Through week 76
Through week 76
Percent change from baseline of anti-Smith antibodies
Time Frame: Through week 76
Through week 76
Absolute values of anti-C1q antibodies
Time Frame: Through week 76
Through week 76
Percent change from baseline of anti-C1q antibodies
Time Frame: Through week 76
Through week 76
Absolute values of other autoantibodies
Time Frame: Through week 76
anti-nucleosome
Through week 76
Percent change from baseline of other autoantibodies
Time Frame: Through week 76
anti-nucleosome
Through week 76
Absolute values of Complement Factor C3 (C3) circulating factors
Time Frame: Through week 76
Through week 76
Percent change from baseline of C3 circulating factors
Time Frame: Through week 76
Through week 76
Absolute values of Complement Factor C4 (C4) circulating factors
Time Frame: Through week 76
Through week 76
Percent change from baseline of C4 circulating factors
Time Frame: Through week 76
Through week 76
Absolute values of serum levels of Immunoglobulin A (IgA)
Time Frame: Through week 76
Through week 76
Percent change from baseline of serum levels of IgA
Time Frame: Through week 76
Through week 76
Absolute values of serum levels of Immunoglobulin G (IgG)
Time Frame: Through week 76
Through week 76
Percent change from baseline of serum levels of IgG
Time Frame: Through week 76
Through week 76
Proportion of participants no longer receiving a corticosteroid
Time Frame: At 6 months
At 6 months
Concentrations of vonsetamig in serum
Time Frame: Through week 76
Through week 76
Concentrations of odronextamab in serum
Time Frame: Through week 76
Through week 76
Occurence of Anti-Drug Antibodies (ADAs) to vonsetamig
Time Frame: Through week 76
Through week 76
Occurence of ADAs to odronextamab
Time Frame: Through week 76
Through week 76
Magnitude of ADAs to vonsetamig
Time Frame: Through week 76
Through week 76
Magnitude of ADAs to odronextamab
Time Frame: Through week 76
Through week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R5459-1979-LN-2459
  • 2024-518288-37-00 (Ctis: EUCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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