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Lupus Nephritis (LN)Phase 1NCT06975787

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

A Phase 1 study testing Vonsetamig and Odronextamab in people with Lupus Nephritis (LN), run by Regeneron Pharmaceuticals at 20 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lupus Nephritis (LN)
What is being tested?
Vonsetamig and Odronextamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
20 sitesin 6 countries
Study dates
22 Dec 2025to 10 Sep 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

20 sites in 6 countries

Spain5 sites, 5 recruiting

  • Hospital Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 290090

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

    Recruiting

Other trials in Spain

United States4 sites, 4 recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • University of California San Francisco - Zuckerberg San Francisco General

    San Francisco, California, 94110

    Recruiting

Other trials in United States

South Korea4 sites, 4 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Yonsei University College of Medicine, Severance Hospital

    Seoul, 3722

    Recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

  • Changhua Christian Hospital

    Changhua, 500

    Recruiting

  • Taichung General Veterans Hospital

    Taichung, 40705

    Recruiting

  • National Taiwan University Hospital

    Taipei, 106

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Recruiting

Other trials in Taiwan

Germany2 sites, 2 recruiting

  • University Medical Center of the Johannes Gutenberg-University Mainz

    Mainz, 55131

    Recruiting

  • University Hospital Regensburg

    Regensburg, Bavaria, D-93053

    Recruiting

Other trials in Germany

France1 site, 1 recruiting

  • Centre Hospitalier Universitaire (CHU) Bordeaux

    Bordeaux, New Aquitaine, 33076

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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)
Being tested
Vonsetamig, Odronextamab
Keywords
Bispecific Antibodies (bsAb), Double-stranded DNA (dsDNA), LN class III or IV, Systemic Lupus Erythematosus (SLE)
Medical subject headings
Lupus Nephritis, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VonsetamigDrug

    Also called REGN5459

    Administered as per the protocol

  • OdronextamabDrug

    Also called REGN1979

    Administered as per the protocol

Study groups in NCT06975787
Study groupRoleWhat they receive
Experimental Arm 1: VonsetamigExperimentalNot described
Receives: Drug: Vonsetamig
Experimental Arm 2: OdronextamabExperimentalNot described
Receives: Drug: Odronextamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Dose Limiting Toxicities (DLT)

    Measured: Up to 56 days

  2. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Through week 76

  3. Severity of TEAEs

    Measured: Through week 76

Secondary outcomes (30)

  1. Proportion of participants no longer receiving a corticosteroid

    Measured: At 6 months

  2. Cumulative total exposure to corticosteroids

    Measured: At 76 weeks

  3. Absolute values of urine Protein-Creatinine Ratio (uPCR)

    Measured: Through week 76

  4. Percent change from baseline of uPCR

    Measured: Through week 76

  5. Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine

    Measured: Through week 76

  6. Percent change from baseline of eGFR serum creatinine

    Measured: Through week 76

  7. Absolute values of blood B-cell counts and other immune cell populations

    T cells and Natural Killer (NK) cells

    Measured: Through week 76

  8. Change from baseline of blood B-cell counts and other immune cell populations

    T cells and NK cells

    Measured: Through week 76

  9. Absolute values of double-stranded DNA (dsDNA) antibodies

    Measured: Through week 76

  10. Percent change from baseline of dsDNA antibodies

    Measured: Through week 76

  11. Absolute values of anti-Smith antibodies

    Measured: Through week 76

  12. Percent change from baseline of anti-Smith antibodies

    Measured: Through week 76

  13. Absolute values of anti-C1q antibodies

    Measured: Through week 76

  14. Percent change from baseline of anti-C1q antibodies

    Measured: Through week 76

  15. Absolute values of other autoantibodies

    anti-nucleosome

    Measured: Through week 76

  16. Percent change from baseline of other autoantibodies

    anti-nucleosome

    Measured: Through week 76

  17. Absolute values of Complement Factor C3 (C3) circulating factors

    Measured: Through week 76

  18. Percent change from baseline of C3 circulating factors

    Measured: Through week 76

  19. Absolute values of Complement Factor C4 (C4) circulating factors

    Measured: Through week 76

  20. Percent change from baseline of C4 circulating factors

    Measured: Through week 76

  21. Absolute values of serum levels of Immunoglobulin A (IgA)

    Measured: Through week 76

  22. Percent change from baseline of serum levels of IgA

    Measured: Through week 76

  23. Absolute values of serum levels of Immunoglobulin G (IgG)

    Measured: Through week 76

  24. Percent change from baseline of serum levels of IgG

    Measured: Through week 76

  25. Concentrations of vonsetamig in serum

    Measured: Through week 76

  26. Concentrations of odronextamab in serum

    Measured: Through week 76

  27. Occurence of Anti-Drug Antibodies (ADAs) to vonsetamig

    Measured: Through week 76

  28. Occurence of ADAs to odronextamab

    Measured: Through week 76

  29. Magnitude of ADAs to vonsetamig

    Measured: Through week 76

  30. Magnitude of ADAs to odronextamab

    Measured: Through week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start22 Dec 2025
  3. Primary completion10 Sep 2029 (estimated)
  4. Study completion10 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975787
Sponsor's protocol ID
R5459-1979-LN-2459
Other IDs
2024-518288-37-00
Status last verified
Oct 2026
First submitted
8 May 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vonsetamig and Odronextamab in people with Lupus Nephritis (LN), run by Regeneron Pharmaceuticals at 20 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain, United States, South Korea, Taiwan, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Dose Limiting Toxicities (DLT) (time frame: Up to 56 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06975787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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