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Study on the Long-Term Safety of Dapirolizumab Pegol for Patients with Systemic Lupus Erythematosus

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining 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.

  2. Step 2

    Treatment 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).

  3. Step 3

    Monitoring 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.

  4. Step 4

    Assessment 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.

  5. Step 5

    Completion 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 trial?

6 criteria

  • 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 trial?

9 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Dapirolizumab Pegol – This medication is administered through an injection, typically given under the skin. It is currently being studied in clinical trials to assess its long-term safety and tolerability for treating systemic lupus erythematosus (SLE), a chronic autoimmune disease. Dapirolizumab Pegol works by targeting and modulating specific immune system components to reduce inflammation and disease activity. It belongs to the pharmacological class of monoclonal antibodies, which are designed to interact with specific proteins in the body to achieve their therapeutic effects.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506368-14-00Protocol codeSL0046Estimated enrolment760 patientsSponsorUCB Biopharma

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