Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis
- Registration Number
- NCT06975787
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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
Key General
- 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
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental Arm 1: Vonsetamig Vonsetamig -
- Primary Outcome Measures
Name Time Method Occurrence of Dose Limiting Toxicities (DLT) Up to 49 days Occurrence of Treatment Emergent Adverse Events (TEAEs) Through week 52 Severity of TEAEs Through week 52
- Secondary Outcome Measures
Name Time Method Proportion of participants receiving a corticosteroid dose of 0 mg per day At 6 months Cumulative total exposure to corticosteroids At 52 weeks Absolute values of urine Protein-Creatinine Ratio (uPCR) Through week 52 Percent change from baseline of uPCR Through week 52 Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine Through week 52 Percent change from baseline of eGFR serum creatinine Through week 52 Absolute values of blood B-cell counts and other immune cell populations Through week 52 T cells and Natural Killer (NK) cells
Change from baseline of blood B-cell counts and other immune cell populations Through week 52 T cells and NK cells
Absolute values of double-stranded DNA (dsDNA) antibodies Through week 52 Percent change from baseline of dsDNA antibodies Through week 52 Absolute values of anti-Smith antibodies Through week 52 Percent change from baseline of anti-Smith antibodies Through week 52 Absolute values of anti-C1q antibodies Through week 52 Percent change from baseline of anti-C1q antibodies Through week 52 Absolute values of other autoantibodies Through week 52 anti-nucleosome
Percent change from baseline of other autoantibodies Through week 52 anti-nucleosome
Absolute values of Complement Factor C3 (C3) circulating factors Through week 52 Percent change from baseline of C3 circulating factors Through week 52 Absolute values of Complement Factor C4 (C4) circulating factors Through week 52 Percent change from baseline of C4 circulating factors Through week 52 Absolute values of serum levels of Immunoglobulin A (IgA) Through week 52 Percent change from baseline of serum levels of IgA Through week 52 Absolute values of serum levels of Immunoglobulin G (IgG) Through week 52 Percent change from baseline of serum levels of IgG Through week 52 Concentrations of study drug in serum over time Through week 52 Incidence of Anti-Drug Antibodies (ADAs) to study drug Through week 52 Titer of ADAs to study drug Through week 52