Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
RecruitingRare disease
Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease
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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 for a condition called systemic sclerosis associated interstitial lung disease (SSc-ILD). This condition is a type of lung disease that occurs in people with systemic sclerosis, a rare autoimmune disease that causes hardening and tightening of the skin and connective tissues. The treatment being studied is a medication called belimumab, which is given as an injection under the skin using a pre-filled pen.
The purpose of the study is to understand how safe and tolerable belimumab is for people with SSc-ILD over a long period. Participants in the study will receive belimumab injections and will be monitored regularly to check for any side effects and to see how their lung function changes over time. The study will continue for several years to gather comprehensive data on the treatment's long-term effects.
Participants will be asked to visit the study site at specific intervals for assessments, which may include checking lung function and overall health. The study aims to provide valuable information on the use of belimumab for treating SSc-ILD, potentially offering a new option for managing this challenging condition.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Participants must have a condition called **SSc-ILD** and have completed a previous study up to the Week 52 visit without being considered a treatment failure. Treatment failure means starting new medications for the disease or stopping the study medication for any reason.
- Participants should have an area of skin that is not too thick, allowing for an injection under the skin, either on the belly or the front, middle part of the thigh.
- Participants must be able and willing to give themselves the study medication or have someone, like a caregiver or healthcare professional, who can do it for them during the study.
- Female participants must not be pregnant or breastfeeding. They must either be unable to have children or, if they can have children, use a very effective birth control method during the study and for at least 4 months after the last dose of the study medication. They must also have a negative pregnancy test before starting the study medication.
- Participants must be able to give signed informed consent, which means they agree to follow the study's rules and requirements.
Who cannot join the trial?
1 criterion
- Individuals with **bronchial diseases** cannot participate. This refers to any condition affecting the airways in the lungs.
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Verified sites
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Complexo Hospitalario Universitario De Vigo
Responsive
Vigo, SpainFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
ResponsiveMadrid, Spain
Trial locations
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Investigated drugs
Belimumab is a medication used in this clinical trial to study its long-term safety and effectiveness in adults with systemic sclerosis associated with interstitial lung disease (SSc-ILD). It is administered through an injection under the skin. The goal is to see how well patients tolerate the medication over an extended period and to monitor any potential side effects.
What is already known about the treatment
Belimumab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied for its long-term safety and effectiveness in treating systemic sclerosis associated interstitial lung disease (SSc-ILD). Belimumab is primarily used for conditions related to the immune system, such as lupus. It works by inhibiting a specific protein that plays a role in the activity of certain immune cells, helping to reduce inflammation and immune response. Belimumab is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with specific pathways in the immune system.
Investigated diseases
Bronchial Diseases – These are conditions that affect the bronchi, which are the main passageways into the lungs. They can cause symptoms such as coughing, wheezing, and difficulty breathing. Over time, these diseases may lead to inflammation and narrowing of the airways, making it harder for air to move in and out of the lungs. Common types include bronchitis and asthma, each with varying degrees of severity and progression. Chronic forms can result in persistent symptoms and may require ongoing management. Environmental factors, infections, and genetic predispositions can influence the development and progression of these diseases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509370-39-00Protocol code219855Estimated enrolment500 patientsSponsorGlaxosmithkline Research & Development Limited
sourced from the EU Clinical Trials Register and site verification
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