This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called dapirolizumab pegol for people with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the body’s immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The purpose of this study is to evaluate how well patients tolerate this treatment over an extended period.
Participants in this study will receive dapirolizumab pegol through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor participants for any side effects or adverse reactions that may occur during the treatment. The study will also assess whether the treatment can help prevent severe flare-ups of the disease, which are periods when symptoms become more intense.
The study will last for a total of 104 weeks, during which participants will have regular check-ups to track their progress and any changes in their condition. The goal is to ensure that the treatment is safe and effective for long-term use in managing Systemic Lupus Erythematosus. Participants who have completed a previous study involving a placebo may be eligible to join this extension study to continue receiving the treatment.
1joining the study
Upon joining the study, the participant must have completed a previous study within the last four weeks. This ensures continuity in treatment and monitoring.
2treatment with dapirolizumab pegol
The participant will receive dapirolizumab pegol, a medication administered through an intravenous infusion. This treatment is designed to evaluate its long-term safety and tolerability in individuals with systemic lupus erythematosus (SLE).
3monitoring for adverse events
Throughout the study, the participant will be monitored for any adverse events that may occur as a result of the treatment. This includes both general adverse events and serious ones that could lead to discontinuation of the medication.
4assessment of treatment effectiveness
The study will assess the effectiveness of the treatment in preventing severe flares of the disease. This will be evaluated at various intervals: through Week 24, Week 52, and Week 104.
Additionally, the study will measure the achievement of low disease activity and response to treatment at these same intervals.
5completion of the study
The study is expected to conclude by April 10, 2029. The participant’s involvement will continue until the study’s end or until they choose to withdraw or are advised to discontinue for medical reasons.
Who Can Join the Study?
The participant must have a condition called Systemic lupus erythematosus (SLE), which is a disease where the immune system attacks the body’s own tissues.
The participant should be someone who, according to the study doctor, could benefit from long-term treatment with a medication called dapirolizumab pegol (DZP).
The participant must have completed a previous study that compared DZP with a placebo (a substance with no active medication) within the last 4 weeks before joining this study.
Both males and females are eligible to participate in the study.
The study includes participants from different age groups, including children, adults, and older adults.
The study may include individuals who are considered part of a vulnerable population, meaning they might need extra protection or care.
Who Cannot Join the Study?
Patients who have a history of severe allergic reactions to the study medication or similar drugs.
Patients with active infections that require treatment with antibiotics or antiviral medications.
Patients who are pregnant or breastfeeding.
Patients with a history of cancer within the last five years, except for certain types of skin cancer.
Patients with severe heart disease or uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients who have received another investigational drug within the last 30 days.
Patients with a history of drug or alcohol abuse within the last year.
Patients who have a condition that, in the opinion of the study doctor, would make participation unsafe or affect the study results.
Dapirolizumab Pegol (DZP) is a medication being studied for its long-term safety and tolerability in patients with Systemic Lupus Erythematosus (SLE). This medication is designed to help manage the symptoms of SLE, which is an autoimmune disease where the body’s immune system attacks its own tissues. The study aims to understand how well patients can tolerate this treatment over an extended period and to monitor any potential side effects.
Systemic lupus erythematosus (SLE) – This is an autoimmune disease where the body’s immune system mistakenly attacks healthy tissue. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, rash, and fever, which can vary in severity and may come and go. The disease progresses with periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, SLE can lead to damage in the affected organs and tissues. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.
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