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
2 other identifiers
interventional
90
5 countries
11
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2025
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 23, 2028
April 13, 2026
April 1, 2026
2.6 years
May 8, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Occurrence of Dose Limiting Toxicities (DLT)
Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Through week 76
Severity of TEAEs
Through week 76
Secondary Outcomes (30)
Proportion of participants receiving a corticosteroid dose of 0 mg per day
At 6 months
Cumulative total exposure to corticosteroids
At 76 weeks
Absolute values of urine Protein-Creatinine Ratio (uPCR)
Through week 76
Percent change from baseline of uPCR
Through week 76
Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine
Through week 76
- +25 more secondary outcomes
Study Arms (2)
Experimental Arm 1: Vonsetamig
EXPERIMENTALExperimental Arm 2: Odronextamab
EXPERIMENTALInterventions
Administered as per the protocol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, 55131, Germany
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Regional Universitario de Malaga
Málaga, 290090, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
Taichung General Veterans Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 106, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 16, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
July 23, 2028
Study Completion (Estimated)
July 23, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.