RecruitingPhase 1NCT06975787

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

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

Sponsor

Regeneron Pharmaceuticals

Enrollment

90 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Lupus Nephritis (LN)

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

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

Exclusion Criteria3

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

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