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

RecruitingPhase 1Ages 18 Years - 60 YearsAllRegeneron Pharmaceuticals
NCT06975787 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Vonsetamig
  • Odronextamab
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Where

19 sites
University of California San Francisco - Zuckerberg San Francisco General
San Francisco, United States
Mayo Clinic
Rochester, United States
Baylor College of Medicine
Houston, United States
Centre Hospitalier Universitaire (CHU) Bordeaux
Bordeaux, France
University Hospital Regensburg
Regensburg, Germany
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Germany
Hallym University Sacred Heart Hospital
Anyang-si, South Korea
Seoul National University Hospital
Seoul, South Korea

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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