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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Krankenhaus Porz Am Rhein gGmbH	Cologne	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
General University Hospital Of Larissa	Larissa	Greece
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
424 Military General Training Hospital	Thessaloniki	Greece
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania	Catania	Italy
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Turku University Hospital	Turku	Finland
Universita’ Politecnica Delle Marche	Ancona	Italy
Region Midtjylland	Aarhus	Denmark
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Muehlenkreiskliniken AöR	Minden	Germany
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
University General Hospital Of Heraklion	Heraklion	Greece
Hospital Universitario Basurto	Bilbao	Spain
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Assistance Publique Hopitaux De Paris	Creteil	France
University Hospital Consorziale Policlinico	Bari	Italy
Tbbwylcpfdc uoq Spupdszslog Biakpkpx Gorf	Bad Bentheim	Germany
Ksbahiiekajtk Sts Ayllifuz ush Sst Jogky Gekd	Wuppertal	Germany
Audbhexrxc Pyyclrxk Hthsggef Df Pptbx	Paris	France
Uoiyddthiajwksebcolib Dmxznbjwlre Aqb	Duesseldorf	Germany
Hxbsqvpa Dt Ll Stpfa Cvhi I Sfra Pmv	Barcelona	Spain
Umvmujxemo Ddrke Svrxb Dt Rnxu Lg Subntiiz	Rome	Italy
Fudbfzdfa Pnbh Ls Ixhqpjmikswzb Bndilgfrj Dpf Huevuaau Ususjseurcqpa Lk Phf	Madrid	Spain
Cgbpuydo Hjhbxskvredw Uowupcxojklhe Dl Vopj	Vigo	Spain
Hwiazbli Vknn dbnfidwm	Barcelona	Spain
Uihzqwmxch Gkydudt Htijzhfy Arowswc	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	05.01.2024
Denmark	Not recruiting	05.01.2024
Finland	Not recruiting	05.01.2024
France	Recruiting	05.01.2024
Germany	Recruiting	05.01.2024
Greece	Recruiting	05.01.2024
Italy	Recruiting	05.01.2024
Spain	Recruiting	05.01.2024

Trial locations

Investigated drugs:

Belimumab

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.

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 ID:

2023-503219-14-01

Protocol code:

218224

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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