Lupus Nephritis (LN)
Conditions
Keywords
Bispecific Antibodies (bsAb), Double-stranded DNA (dsDNA), LN class III or IV, Systemic Lupus Erythematosus (SLE)
Brief summary
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: * 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)
Interventions
DRUGVonsetamig
Administered as per the protocol
DRUGOdronextamab
Administered as per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Key General Inclusion Criteria: 1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol 2. Participant must have refractory or relapsed disease, as described in the protocol Key General
Exclusion criteria
1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization 2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening 3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening NOTE: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | Through week 76 | T cells and Natural Killer (NK) cells |
| Change from baseline of blood B-cell counts and other immune cell populations | Through week 76 | T cells and NK cells |
| 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 | Through week 76 | anti-nucleosome |
| Percent change from baseline of other autoantibodies | Through week 76 | anti-nucleosome |
| 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 | — |
Countries
France, Germany, South Korea, Spain, Taiwan, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed