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Clinical Trials in South Korea / NCT06975787
Recruiting Phase 1

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

NCT06975787 · tracked via the Priya Life Science South Korea tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 1
Started
2025-12-22
Last updated
2026-09-14

Condition(s) studied

Lupus Nephritis (LN)

Investigational drug(s) / intervention(s)

Vonsetamig →Odronextamab →

Vonsetamig: Administered as per the protocol

Odronextamab: Administered as per the protocol

Study 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.

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

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

More Regeneron Pharmaceuticals trials in South Korea

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) Recruiting
A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) Active, not recruiting
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma Recruiting
A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06975787 on ClinicalTrials.gov ↗ ← All trials in South Korea