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Study on the Effectiveness and Safety of Dapirolizumab Pegol for Patients with Moderate to Severe Systemic Lupus Erythematosus

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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 effects of a medication called dapirolizumab pegol in people with systemic lupus erythematosus (SLE)</b), a condition where the immune system attacks the body's own tissues, causing inflammation and damage. The study aims to determine if dapirolizumab pegol, when added to standard treatments, can help improve the symptoms of moderate to severe SLE. Participants in the study will receive either dapirolizumab pegol or a placebo, which looks like the medication but does not contain the active substance.

The study will take place over a period of time, during which participants will receive the treatment through an infusion, which means the medication is given directly into a vein. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to see if the medication can provide a long-term improvement in the disease activity of SLE.

In addition to dapirolizumab pegol, participants will continue their usual standard of care treatments, which may include medications like antimalarials, corticosteroids, and immunosuppressants. These are commonly used to manage SLE symptoms. The study will help researchers understand if adding dapirolizumab pegol to these treatments can offer additional benefits for people living with SLE.

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 will be randomly assigned to receive either the investigational medication, dapirolizumab pegol, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Treatment administration

    The participant will receive dapirolizumab pegol or placebo as a solution for infusion. This means the medication is given directly into a vein through an intravenous (IV) line.

    The frequency and dosage of the infusion will be determined by the study protocol and will be administered at regular intervals throughout the study period.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will occur to assess the participant's response to the treatment. This includes evaluating the disease activity using specific criteria and scales designed for systemic lupus erythematosus (SLE).

    Assessments will be conducted at various time points, including weeks 12, 24, and 48, to measure the effectiveness and safety of the treatment.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation will be conducted to determine the overall impact of the treatment on the participant's condition.

    This evaluation will include a review of any adverse events experienced during the study and the participant's overall health status.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits may be scheduled to monitor the participant's health and any long-term effects of the treatment.

Who can join the trial?

16 criteria

  • The participant must be at least 16 years old at the time of signing the consent form.
  • The participant should have moderate to severe disease activity due to ongoing active **systemic lupus erythematosus (SLE)** or a sudden worsening of SLE, even with stable standard treatment.
  • The participant must have been diagnosed with SLE at least 24 weeks before the screening visit by a qualified doctor.
  • The participant should meet the 2019 classification criteria for SLE set by the European League Against Rheumatism and the American College of Rheumatology.
  • There must be **serological evidence** for SLE at screening, shown by at least one of the following:
  • Evidence of **anti-dsDNA antibodies**, which are specific proteins found in the blood.
  • Low levels of **complement proteins** C3 or C4, which are part of the immune system.
  • Presence of **antinuclear antibodies** with a specific titer, along with at least one of the following SLE-related antibodies:
  • **Anti-Smith (anti-Sm) antibodies**
  • **Anti-Sjögren’s syndrome antibodies** (Anti-SSA/Ro or Anti-SSB/La)
  • Historical evidence of anti-dsDNA antibodies
  • **Anti-ribonucleoprotein (RNP) antibodies**
  • The participant must have moderate to severe active disease, defined by specific scores on the **British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)** and the **Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)** at screening and baseline visits.
  • The participant should be receiving stable doses of standard treatment, which may include:
  • **Antimalarial treatment** with or without corticosteroids and/or immunosuppressants
  • Only corticosteroids and/or immunosuppressants if antimalarial treatment is not suitable due to intolerance, lack of effectiveness, contraindications, or unavailability

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments recently that could affect the study results.
  • Patients with a history of substance abuse that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients with certain infections that could affect their participation in the study.
  • Patients who have had a recent surgery that might impact the study.
  • Patients with a history of certain mental health conditions that could interfere with the study.
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Investigated drugs

Dapirolizumab Pegol (DZP) is being studied to see if it can help people with moderately to severely active systemic lupus erythematosus. It is used in addition to the standard treatments that patients are already receiving. The goal is to find out if this medication can provide a significant and lasting improvement in the symptoms of the disease.

What is already known about the treatment

Dapirolizumab Pegol – This medication is administered through an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating systemic lupus erythematosus (SLE), a chronic autoimmune disease. The main therapeutic indication for dapirolizumab pegol is to reduce the activity of the immune system in patients with moderate to severe SLE. At the molecular level, it works by targeting and inhibiting specific proteins involved in the immune response, helping to decrease inflammation and disease activity. It is classified as a monoclonal antibody, a type of medication designed to interact with specific targets in the body.

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 is characterized by periods of illness, called flares, and periods of remission when 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 ID2023-508191-11-00Protocol codeSL0044Estimated enrolment450 patientsSponsorUCB Biopharma

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