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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT06975787

Registry updated: 2026-09-14
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Description

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)

Interventions

  • Vonsetamig (Drug)
    Administered as per the protocol
  • Odronextamab (Drug)
    Administered as per the protocol

Eligibility criteria

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

Conditions

Lupus Nephritis (LN)

Locations

  • University of California San Francisco - Zuckerberg San Francisco General — San Francisco, California, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • Baylor College of Medicine — Houston, Texas, United States
  • Centre Hospitalier Universitaire (CHU) Bordeaux — Bordeaux, New Aquitaine, France
  • University Hospital Regensburg — Regensburg, Bavaria, Germany
  • University Medical Center of the Johannes Gutenberg-University Mainz — Mainz, Germany
  • Hallym University Sacred Heart Hospital — Anyang-si, Gyeonggi-do, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Yonsei University College of Medicine, Severance Hospital — Seoul, South Korea
  • Hospital Universitario Virgen del Rocio — Seville, Andalusia, Spain
  • Clinica Universidad de Navarra — Pamplona, Navarre, Spain
  • Hospital Gregorio Maranon — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Regional Universitario de Malaga — Málaga, Spain
  • Changhua Christian Hospital — Changhua, Taiwan
  • Taichung General Veterans Hospital — Taichung, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record