Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
Recruiting · NCT06975787 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
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
Where it is running
18 locations listed across 2 US states.
- Mayo Clinic - Rochester, Minnesota, United States
- Baylor College of Medicine - Houston, Texas, United States
- Changhua Christian Hospital - Changhua, Taiwan
- Hospital Gregorio Maranon - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- University Medical Center of the Johannes Gutenberg-University Mainz - Mainz, Germany
- Hospital Regional Universitario de Malaga - Málaga, Spain
- Seoul National University Hospital - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Yonsei University College of Medicine, Severance Hospital - Seoul, South Korea
- Taichung General Veterans Hospital - Taichung, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- Hospital Universitario Virgen del Rocio - Seville, Andalusia, Spain
- University Hospital Regensburg - Regensburg, Bavaria, Germany
- Hallym University Sacred Heart Hospital - Anyang-si, Gyeonggi-do, South Korea
- Clinica Universidad de Navarra - Pamplona, Navarre, Spain
- Centre Hospitalier Universitaire (CHU) Bordeaux - Bordeaux, New Aquitaine, France