NCT06975787

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Lupus Nephritis (LN)

Interventions

Type	Name	Description
DRUG	Vonsetamig	Administered as per the protocol
DRUG	Odronextamab	Administered as per the protocol

Timeline

• Start date: 2025-12-22
• Primary completion: 2028-07-23
• Completion: 2028-07-23
• First posted: 2025-05-16
• Last updated: 2026-04-13

Locations

11 sites across 5 countries: United States, Germany, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study