Study on the Long-Term Safety of Belimumab for Adults with Systemic Sclerosis-Related Lung Disease

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What is this study about?

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.

1 introduction to the study

The study focuses on the long-term safety and effectiveness of belimumab for individuals with systemic sclerosis associated interstitial lung disease (SSc-ILD).

Participants must have completed a previous study and meet specific criteria to join this extension study.

2 medication administration

The medication used in this study is Benlysta 200 mg, a solution for injection.

The medication is administered through a subcutaneous injection, which means it is injected under the skin.

Participants or their caregivers must be capable and willing to administer the medication throughout the study.

3 monitoring and assessments

Participants will be monitored for any adverse effects, which are unexpected reactions to the medication.

Regular assessments will be conducted to measure lung function, specifically the forced vital capacity (FVC), at specified intervals such as weeks 12, 26, and 52, and then every 52 weeks.

4 duration of the study

The study is expected to continue until December 31, 2029.

Participants will be involved in the study for an extended period, with regular follow-ups to ensure safety and effectiveness of the treatment.

Who Can Join the Study?

  • 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 Study?

  • Individuals with bronchial diseases cannot participate. This refers to any condition affecting the airways in the lungs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
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 di Padova Padua Italy
General University Hospital Of Larissa Larissa Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Degli Studi Di Verona Verona Italy
Turku University Hospital Turku Finland
Virgen del Rocío University Hospital Sevilla Spain
Universita’ Politecnica Delle Marche Ancona Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Region Midtjylland Aarhus Denmark
Hopital Beaujon Clichy France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
University Hospital Consorziale Policlinico Bari Italy
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Crtqcswz Hyepgttskzqk Uofgsjxfgrqze Du Vfsz Vigo Spain
Hwcpmwvo Db Ly Syrma Cxeh I Sonm Phs Barcelona Spain
Uspexxkpft Dlgdh Siqly Di Rgnm Lp Sairwzsw Rome Italy
Fvqsjjkbr Ptgt Lw Icjravwhdhwnc Bootoreyc Djk Hsyknwem Uocryydotajdm Lj Pir Madrid Spain
Unykijpbtxapwiiuoarnv Drpdaqjikkj Acs Duesseldorf Germany
Hdlowefh Vyvg dqjznzxc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
20.04.2025
Denmark Denmark
Not yet recruiting
20.04.2025
Finland Finland
Not yet recruiting
20.04.2025
France France
Recruiting
20.04.2025
Germany Germany
Recruiting
20.04.2025
Greece Greece
Recruiting
20.04.2025
Italy Italy
Recruiting
20.04.2025
Spain Spain
Recruiting
20.04.2025

Trial locations

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.

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 ID:
2023-509370-39-00
Protocol code:
219855
Trial Phase:
Therapeutic confirmatory (Phase III)

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