Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus (GARDENIA)

Systemic lupus erythematosus (SLE) is a chronic condition in which the immune system mistakenly attacks its own healthy tissue, causing swelling and redness in various organs. SLE can often lead to repeated kidney inflammation, which can result in kidney failure. It can also cause serious health problems due to treatments and, in some cases, lead to death. The current therapies for SLE generally work by treating symptoms or suppressing the immune system. Therefore, there is a need for new treatment options that work better.
Nipocalimab is a type of monoclonal antibody* that selectively blocks the binding site of immunoglobulin (IgG) on a protein called the endogenous neonatal Fc receptor (FcRn). This leads to a reduction in circulating IgG and therefore a reduction in the inflammatory immune response to harmful IgG in the body.

• A type of protein designed to recognize and bind to a specific target. In this clinical trial, researchers want to find out how well Nipocalimab works in patients with moderate to severe SLE compared to a placebo. The trial consists of the following phases: screening phase (6 weeks), double-blind treatment phase (week 0 to week 52), open-label long-term extension phase (week 52 to week 156), and safety follow-up phase (up to week 162). Safety assessments include monitoring for adverse events (AEs), serious AEs, and AEs of special interest, laboratory parameters, blood pressure monitoring, injection site reactions, infections, and allergic reactions (mild to severe). The total duration of the clinical trial is approximately 3 years and 1 month.

Nipocalimab, a new medication that binds circulating immune cells and may reduce the inflammatory immune response.
Systemic lupus erythematosus (SLE) is a chronic condition in which the immune system mistakenly attacks its own healthy tissue, causing swelling and redness in various organs. SLE can often lead to repeated kidney inflammation, which can result in kidney failure. It can also cause serious health problems due to treatments and, in some cases, lead to death. The current therapies for SLE generally work by treating symptoms or suppressing the immune system. Therefore, there is a need for new treatment options that work better.
Nipocalimab is a type of monoclonal antibody* that selectively blocks the binding site of immunoglobulin (IgG) on a protein called the endogenous neonatal Fc receptor (FcRn). This leads to a reduction in circulating IgG and therefore a reduction in the inflammatory immune response to harmful IgG in the body.

• A type of protein designed to recognize and bind to a specific target. In this clinical trial, researchers want to find out how well Nipocalimab works in patients with moderate to severe SLE compared to a placebo. The trial consists of the following phases: screening phase (6 weeks), double-blind treatment phase (week 0 to week 52), open-label long-term extension phase (week 52 to week 156), and safety follow-up phase (up to week 162). Safety assessments include monitoring for adverse events (AEs), serious AEs, and AEs of special interest, laboratory parameters, blood pressure monitoring, injection site reactions, infections, and allergic reactions (mild to severe). The total duration of the clinical trial is approximately 3 years and 1 month.

Systemic lupus erythematosus (SLE) is a chronic condition in which the immune system mistakenly attacks its own healthy tissue, causing swelling and redness in various organs.