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NCT06975787PHASE1Recruiting

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

Regeneron Pharmaceuticals

Start Date

12/22/2025

Completion Date

9/9/2029

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 Criteria

Age Range: 18 years to 60 years

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

Interventions

DRUG

Vonsetamig

DRUG

Odronextamab

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Conditions

Lupus Nephritis (LN)

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Centre Hospitalier Universitaire (CHU) Bordeaux

Bordeaux, New Aquitaine 33076

France

University Hospital Regensburg

Regensburg, Bavaria D-93053

Germany

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, 55131

Germany

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do 14068

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Universitario Virgen del Rocio

Seville, Andalusia 41013

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Gregorio Maranon

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Regional Universitario de Malaga

Málaga, 290090

Spain

Changhua Christian Hospital

Changhua, 500

Taiwan

Taichung General Veterans Hospital

Taichung, 40705

Taiwan

National Taiwan University Hospital

Taipei, 106

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan