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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518288-37-00 | EU Trial (CTIS) Number |
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This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1: Vonsetamig | Experimental |
| |
| Experimental Arm 2: Odronextamab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonsetamig | Drug | Administered as per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants no longer receiving a corticosteroid | At 6 months | |
| Cumulative total exposure to corticosteroids | At 76 weeks | |
| Absolute values of urine Protein-Creatinine Ratio (uPCR) |
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Key General Inclusion Criteria:
Key General Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States | |
| Baylor College of Medicine |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
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
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| Odronextamab | Drug | Administered as per the protocol |
|
|
| 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 |
| Percent change from baseline of eGFR serum creatinine | Through week 76 |
| Absolute values of blood B-cell counts and other immune cell populations | T cells and Natural Killer (NK) cells | Through week 76 |
| Change from baseline of blood B-cell counts and other immune cell populations | T cells and NK cells | Through week 76 |
| Absolute values of double-stranded DNA (dsDNA) antibodies | Through week 76 |
| Percent change from baseline of dsDNA antibodies | Through week 76 |
| Absolute values of anti-Smith antibodies | Through week 76 |
| Percent change from baseline of anti-Smith antibodies | Through week 76 |
| Absolute values of anti-C1q antibodies | Through week 76 |
| Percent change from baseline of anti-C1q antibodies | Through week 76 |
| Absolute values of other autoantibodies | anti-nucleosome | Through week 76 |
| Percent change from baseline of other autoantibodies | anti-nucleosome | Through week 76 |
| Absolute values of Complement Factor C3 (C3) circulating factors | Through week 76 |
| Percent change from baseline of C3 circulating factors | Through week 76 |
| Absolute values of Complement Factor C4 (C4) circulating factors | Through week 76 |
| Percent change from baseline of C4 circulating factors | Through week 76 |
| Absolute values of serum levels of Immunoglobulin A (IgA) | Through week 76 |
| Percent change from baseline of serum levels of IgA | Through week 76 |
| Absolute values of serum levels of Immunoglobulin G (IgG) | Through week 76 |
| Percent change from baseline of serum levels of IgG | Through week 76 |
| Concentrations of vonsetamig in serum | Through week 76 |
| Concentrations of odronextamab in serum | Through week 76 |
| Occurence of Anti-Drug Antibodies (ADAs) to vonsetamig | Through week 76 |
| Occurence of ADAs to odronextamab | Through week 76 |
| Magnitude of ADAs to vonsetamig | Through week 76 |
| Magnitude of ADAs to odronextamab | Through week 76 |
| Recruiting |
| Houston |
| Texas |
| 77030 |
| United States |
| Centre Hospitalier Universitaire (CHU) Bordeaux | Recruiting | Bordeaux | New Aquitaine | 33076 | France |
| University Hospital Regensburg | Recruiting | Regensburg | Bavaria | D-93053 | Germany |
| University Medical Center of the Johannes Gutenberg-University Mainz | Recruiting | Mainz | 55131 | Germany |
| Hallym University Sacred Heart Hospital | Recruiting | Anyang-si | Gyeonggi-do | 14068 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Yonsei University College of Medicine, Severance Hospital | Recruiting | Seoul | 3722 | South Korea |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Andalusia | 41013 | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Hospital Gregorio Maranon | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | 290090 | Spain |
| Changhua Christian Hospital | Recruiting | Changhua | 500 | Taiwan |
| Taichung General Veterans Hospital | Recruiting | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 106 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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