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Study on the Effects and Safety of Belimumab for Adults with Early 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 belimumab in adults with a condition known as Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease where the body's immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication being tested, belimumab, is administered as a solution for injection using a pre-filled pen. The purpose of the study is to evaluate how effective and safe belimumab is when given to patients with early stages of SLE.

Participants in the study will receive belimumab through subcutaneous injections, which means the medication is injected under the skin. The study will observe participants over a period of time to see how well the medication works in controlling the symptoms of SLE and whether it helps achieve a state called LLDAS, which stands for Low Lupus Disease Activity State, by week 52. The study will also monitor the safety of the medication and any side effects that may occur during the treatment period.

The study will continue to follow participants for up to 156 weeks to gather more information on the long-term effects of belimumab. This includes checking if participants can maintain a stable condition without severe flare-ups and if they can reduce their use of other medications like prednisone, a type of steroid. The trial aims to provide valuable insights into the management of SLE with belimumab, potentially improving treatment options for those affected by this chronic condition.

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

    Initial visit

    Upon joining the study, the first step involves an initial visit. During this visit, a detailed review of your medical history and current health status will be conducted.

    You will undergo a series of tests to confirm your eligibility for the study, including blood tests to check for specific antibodies related to systemic lupus erythematosus (SLE).

  2. Step 2

    Treatment initiation

    Once eligibility is confirmed, the treatment phase begins. You will receive a medication called belimumab, which is administered as a subcutaneous injection using a pre-filled pen.

    The dosage is 200 mg and it will be administered according to the schedule provided by the study team.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the study, you will continue to receive the belimumab injections. Regular follow-up visits will be scheduled to monitor your response to the treatment and any side effects.

    These visits will include physical examinations, blood tests, and questionnaires to assess your health and the effectiveness of the treatment.

  4. Step 4

    Evaluation at week 52

    At week 52, a comprehensive evaluation will be conducted to assess the primary goal of the study, which is achieving a low disease activity state.

    Additional assessments will be made to evaluate secondary outcomes, such as the reduction in the use of oral prednisone and the incidence of severe flare-ups.

  5. Step 5

    Extended follow-up

    For participants continuing in the extended part of the study, further evaluations will occur at weeks 104 and 156 to monitor long-term outcomes.

    These evaluations will focus on maintaining disease remission and monitoring any adverse events.

Who can join the trial?

13 criteria

  • Must be at least 18 years old at the time of signing the consent form.
  • Must have a documented clinical diagnosis of Systemic Lupus Erythematosus (SLE) within 2 years of signing the consent form, according to specific classification criteria from 2019.
  • Must have positive results from an autoantibody test, which checks for specific proteins in the blood that are often present in people with SLE. This includes:
    • An ANA titer of 1:80 or higher, which is a test for antinuclear antibodies.
    • A positive anti-dsDNA test, which measures antibodies against double-stranded DNA, with a result of 30 IU/mL or higher.
    • Must have active SLE, confirmed by a specific scoring system called Clinical SLEDAI-2K, which measures disease activity. This can be:
      • A score greater than 4, or
      • A score of 4 or less with a daily dose of prednisone (a type of steroid medication) or its equivalent of 10 mg or more.
      • Must have an SDI score of 0 at screening, which indicates no organ damage from SLE.
      • Must have an incomplete response to stable initial SLE therapy, which includes:
        • Antimalarials (AMs) started at least 12 weeks before screening and on a stable dose for at least 4 weeks before the study starts.
        • Oral prednisone at a dose of 20 mg/day or less. If not already taking prednisone, it can be started during screening but must remain stable for the last 2 weeks before the study starts.
        • Conventional immunosuppressive (IS) treatment for at least 12 weeks before screening and on a stable dose for at least 4 weeks before the study starts.
        • Can be male or female. Female participants must not be pregnant or breastfeeding and must meet one of the following:
          • Not of childbearing potential, or
          • If of childbearing potential, must use a highly effective contraceptive method with a failure rate of less than 1%.
          • Must be capable of giving signed informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Systemic Lupus Erythematosus (SLE) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who are part of a vulnerable population that the study does not include cannot participate.
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Investigated drugs

Belimumab is a medication used in this clinical trial to help manage systemic lupus erythematosus (SLE), which is a condition where the immune system attacks the body's own tissues. This medication works by targeting a specific protein in the body that is involved in the immune response. By doing so, it helps to reduce the activity of the immune system, which can help decrease the symptoms of lupus and prevent flare-ups. In this study, belimumab is given as an injection under the skin to see how effective and safe it is for people who have been recently diagnosed with lupus.

What is already known about the treatment

Belimumab – Belimumab is administered as an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials for its effectiveness and safety in treating adults with early systemic lupus erythematosus, a chronic autoimmune disease. The main therapeutic use of belimumab is to help manage symptoms of systemic lupus erythematosus by reducing disease activity. At the molecular level, belimumab works by targeting and inhibiting a specific protein in the body called B-lymphocyte stimulator (BLyS), which plays a role in the survival of B cells that contribute to the disease. It is classified as a biologic medication, specifically a monoclonal antibody, which is a type of drug designed to target specific proteins in the body.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. SLE is characterized by periods of illness, called flares, and periods of wellness, or remission. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others having more severe complications. Over time, SLE can lead to damage in the affected organs and tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509146-35-00Protocol code219240Estimated enrolment300 patientsSponsorGlaxosmithkline Research & Development Limited

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