A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis
Regeneron Pharmaceuticals
Summary
This study is researching a particular group of experimental drugs administered for a short period in the treatment of patients 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
- Age range
- 18–60 years
- Sex
- All
- 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…
Interventions
- DrugVonsetamig
Administered as per the protocol
- DrugOdronextamab
Administered as per the protocol
Locations (11)
- Mayo ClinicRochester, Minnesota
- Baylor College of MedicineHouston, Texas
- University Medical Center of the Johannes Gutenberg-University MainzMainz
- Hallym University Sacred Heart HospitalAnyang-si, Gyeonggi-do
- Seoul National University HospitalSeoul
- Samsung Medical CenterSeoul