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NCT Number: NCT06975787

Dose Escalation Study With Bispecific Antibodies in Adult Participants 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)

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Key information

Conditions

Lupus Nephritis (LN) Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier Universitaire (CHU) Bordeaux, Bordeaux, New Aquitaine, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key General Inclusion Criteria:

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

Key General Exclusion Criteria:

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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

Vonsetamig

Drug

Administered as per the protocol

Other names: REGN5459

Odronextamab

Drug

Administered as per the protocol

Other names: REGN1979

Primary outcomes

  1. Occurrence of Dose Limiting Toxicities (DLT)

    Time frame: Up to 56 days

  2. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Through week 76

  3. Severity of TEAEs

    Time frame: Through week 76

Secondary outcomes

  1. Proportion of participants no longer receiving a corticosteroid

    Time frame: At 6 months

  2. Cumulative total exposure to corticosteroids

    Time frame: At 76 weeks

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

    Time frame: Through week 76

  4. Percent change from baseline of uPCR

    Time frame: Through week 76

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

    Time frame: Through week 76

  6. Percent change from baseline of eGFR serum creatinine

    Time frame: Through week 76

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

    Time frame: Through week 76

    T cells and Natural Killer (NK) cells

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

    Time frame: Through week 76

    T cells and NK cells

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

    Time frame: Through week 76

  10. Percent change from baseline of dsDNA antibodies

    Time frame: Through week 76

  11. Absolute values of anti-Smith antibodies

    Time frame: Through week 76

  12. Percent change from baseline of anti-Smith antibodies

    Time frame: Through week 76

  13. Absolute values of anti-C1q antibodies

    Time frame: Through week 76

  14. Percent change from baseline of anti-C1q antibodies

    Time frame: Through week 76

  15. Absolute values of other autoantibodies

    Time frame: Through week 76

    anti-nucleosome

  16. Percent change from baseline of other autoantibodies

    Time frame: Through week 76

    anti-nucleosome

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

    Time frame: Through week 76

  18. Percent change from baseline of C3 circulating factors

    Time frame: Through week 76

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

    Time frame: Through week 76

  20. Percent change from baseline of C4 circulating factors

    Time frame: Through week 76

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

    Time frame: Through week 76

  22. Percent change from baseline of serum levels of IgA

    Time frame: Through week 76

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

    Time frame: Through week 76

  24. Percent change from baseline of serum levels of IgG

    Time frame: Through week 76

  25. Concentrations of vonsetamig in serum

    Time frame: Through week 76

  26. Concentrations of odronextamab in serum

    Time frame: Through week 76

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

    Time frame: Through week 76

  28. Occurence of ADAs to odronextamab

    Time frame: Through week 76

  29. Magnitude of ADAs to vonsetamig

    Time frame: Through week 76

  30. Magnitude of ADAs to odronextamab

    Time frame: Through week 76

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 16, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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