A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
Condition(s) studied
Study summary
This is an open label extension (OLE) study of an ongoing randomized controlled parent clinical studies 218224 (NCT05878717) and 221672 (NCT06572384) which aim to assess the efficacy and safety of belimumab on reducing the decline in lung function in participants with interstitial lung disease associated with diffuse cutaneous systemic sclerosis (dcSSc-ILD) and interstitial lung disease associated with other connective tissue diseases (CTD-ILD), respectively. The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.
Eligibility
Primary outcome measure(s)
- Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs) — Up to approximately 5 years
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | New York | New York | Recruiting |
| GSK Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| GSK Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aire | Argentina | Recruiting |
| GSK Investigational Site | Santa Fe | Argentina | Recruiting |
| GSK Investigational Site | Fitzroy | Victoria | Recruiting |
| GSK Investigational Site | Beijing | China | Recruiting |
| GSK Investigational Site | Beijing | China | Recruiting |
| GSK Investigational Site | Chengdu | China | Recruiting |
| GSK Investigational Site | Hangzhou | China | Recruiting |
| GSK Investigational Site | Mianyang | China | Recruiting |
| GSK Investigational Site | Shanghai | China | Recruiting |
| GSK Investigational Site | Shanghai | China | Recruiting |
| GSK Investigational Site | Shenyang | China | Recruiting |
| GSK Investigational Site | Zhuzhou | China | Recruiting |
| GSK Investigational Site | Toulouse | France | Recruiting |
| GSK Investigational Site | Larissa | Greece | Recruiting |
| GSK Investigational Site | Thessaloniki | Greece | Recruiting |
| GSK Investigational Site | Poria – Neve Oved | Israel | Recruiting |
| GSK Investigational Site | Aichi | Japan | Recruiting |
| GSK Investigational Site | Gunma | Japan | Recruiting |
| GSK Investigational Site | Hiroshima | Japan | Recruiting |
| GSK Investigational Site | Hokkaido | Japan | Recruiting |
| GSK Investigational Site | Tokushima | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Yamanashi | Japan | Recruiting |
| GSK Investigational Site | Bucheon Kyunggi-Do | South Korea | Recruiting |
| GSK Investigational Site | Seoul | South Korea | Recruiting |
| GSK Investigational Site | Suwon Kyunggi-do | South Korea | Recruiting |
| GSK Investigational Site | Yongsan-Ku Seoul | South Korea | Recruiting |
| GSK Investigational Site | Bilbao | Bizkaia | Recruiting |
| GSK Investigational Site | Barcelona | Spain | Recruiting |
| GSK Investigational Site | VigoPontevedra | Spain | Recruiting |
| GSK Investigational Site | Leeds | United Kingdom | Recruiting |
+ 1 more sites — see the full list on the official registry below.
On this site
📄 Benlysta (belimumab) drug profile →More GlaxoSmithKline trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06716606 on ClinicalTrials.gov ↗ ← All trials in France