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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Medical Center of the Johannes Gutenberg-University Mainz
RECRUITING
Mainz
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2028-07-23
Participants
Target number of participants: 90
Treatments
Experimental: Experimental Arm 1: Vonsetamig
Experimental: Experimental Arm 2: Odronextamab
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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