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NCT06975787RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
90 (estimated)
First submitted
8 May 2025
Start date
22 Dec 2025
Primary completion date
10 Sept 2029
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Lupus (SLE)
NCT number
NCT06975787
EU CT number
2024-518288-37-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 90
  • From 22 Dec 2025 to the primary completion date, 10 Sept 2029
  • 20 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainNot yet recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainNot yet recruiting
Clínica Universidad de navarra
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PamplonaSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainNot yet recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceNot yet recruiting
Hallym University Sacred Heart Hospital
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Anyang-siSouth KoreaRecruiting
Yonsei University College of Medicine (Severance Hospital)
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
Taichung General Veterans Hospital
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TaichungTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
University of Florida
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GainesvilleUnited StatesRecruiting
Baylor College of Medicine
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HoustonUnited StatesRecruiting
Mayo Clinic
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RochesterUnited StatesRecruiting
University of California San Francisco - Zuckerberg San Francisco General
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San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.