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Study on the Effects of Belimumab in Adults with Systemic Sclerosis-Associated Interstitial Lung Disease

Fast replyRegistered 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 a condition called systemic sclerosis-associated interstitial lung disease (SSc-ILD). This is a disease where the immune system attacks the body, leading to hardening and thickening of the skin and affecting the lungs. The study will test a treatment called belimumab, which is given as an injection under the skin. Belimumab is being compared to a placebo, which looks like the treatment but does not contain the active medicine.

The purpose of the study is to see if belimumab can help reduce the decline in lung function in people with SSc-ILD. Participants will receive either belimumab or a placebo, in addition to their usual treatment, over a period of 52 weeks. The study will monitor changes in lung volume and other health measures to determine the effectiveness and safety of belimumab.

Participants will be asked to self-administer the injections or have a caregiver do it for them. The study aims to provide more information on whether belimumab can be a helpful treatment for people with SSc-ILD, potentially improving their quality of life by slowing down the progression of lung disease.

The research process

The trial runs in 6 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 informed about the trial's objectives and procedures. The participant will be required to provide informed consent, confirming understanding and agreement to comply with the study requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of systemic sclerosis associated interstitial lung disease and ensuring the participant meets all inclusion criteria.

  3. Step 3

    Randomization

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

  4. Step 4

    Medication administration

    The assigned medication, either belimumab or placebo, will be administered subcutaneously. This involves an injection under the skin, typically in the abdomen or thigh. The medication is provided in a pre-filled syringe containing 200 mg of solution.

    Participants or their caregivers will be instructed on how to self-administer the injections. The frequency and duration of administration will be specified by the study protocol.

  5. Step 5

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor the participant's health and the effects of the treatment. These assessments will include measuring lung function and skin condition, among other health indicators.

  6. Step 6

    Final evaluation

    At the end of the study period, a final evaluation will be conducted. This will include measuring the absolute change from baseline in lung function and other health parameters to assess the efficacy and safety of the treatment.

Who can join the trial?

9 criteria

  • Must be 18 years of age or older.
  • Must have a documented diagnosis of **systemic sclerosis (SSc)**, which is a condition that affects the skin and other organs.
  • Must have **diffuse cutaneous disease**, meaning there is thickened skin over areas near the elbows and/or knees, as well as other areas.
  • Must have **interstitial lung disease**, which is a condition affecting the lungs.
  • Must show signs of active or worsening disease.
  • Must have an area of skin that is not too thick, allowing for an injection under the skin (subcutaneous injection) in the abdomen or front of the thigh.
  • Must be able and willing to give themselves the study medication, or have a caregiver who can do it for them.
  • Female participants must not be pregnant or breastfeeding. They must either not be able to have children or use a highly effective birth control method.
  • Must be able to understand and sign a consent form, agreeing to follow the study's rules and requirements.

Who cannot join the trial?

10 criteria

  • Participants with other serious health conditions that could affect the study results.
  • Individuals who have had a recent infection or illness that could interfere with the study.
  • People who are currently taking medications that might conflict with the study treatment.
  • Participants who have a history of allergic reactions to similar treatments.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Participants with a history of substance abuse that could affect their ability to follow the study procedures.
  • Individuals who have a mental health condition that might make it difficult to comply with the study requirements.
  • People who have had a recent surgery or are planning to have surgery during the study period.
  • Participants who have a condition that affects their immune system, making them more vulnerable to infections.
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Investigated drugs

Belimumab is a medication being studied for its potential to help people with systemic sclerosis associated interstitial lung disease (SSc-ILD). It is given as an injection under the skin. The trial is looking at how well belimumab works in slowing down the loss of lung volume in patients with this condition. It is used in addition to the standard treatments that patients are already receiving.

What is already known about the treatment

Belimumab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating systemic sclerosis associated interstitial lung disease (SSc-ILD). It is not yet fully established in medical practice for this condition, but it is being evaluated for its potential benefits. The main therapeutic indication for belimumab in this trial is to reduce the decline in lung volume in patients with SSc-ILD. At the molecular level, belimumab works by inhibiting a protein called B-lymphocyte stimulator (BLyS), which plays a role in the survival of B cells, a type of white blood cell involved in the immune response. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Systemic Sclerosis Associated Interstitial Lung Disease – This disease is a complication of systemic sclerosis, a condition characterized by the hardening and tightening of the skin and connective tissues. In this form, the disease affects the lungs, leading to inflammation and scarring of lung tissue, known as interstitial lung disease. This scarring can cause the lungs to become stiff, making it difficult for them to expand fully and for the person to breathe deeply. Over time, this can lead to a decrease in lung function and reduced oxygen levels in the blood. The progression of the disease can vary, with some individuals experiencing a slow decline in lung function, while others may have a more rapid progression. Symptoms often include shortness of breath, a persistent dry cough, and fatigue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-503219-14-01Protocol code218224Estimated enrolment300 patientsSponsorGlaxosmithkline Research & Development Limited

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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