A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Belimumab: Belimumab will be administered.
Placebo: Placebo will be administered.
Study summary
Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.
Eligibility
Primary outcome measure(s)
- Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52 — Baseline and Week 52
Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.
Trial sites (132)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Orange | California | Recruiting |
| GSK Investigational Site | San Francisco | California | Recruiting |
| GSK Investigational Site | Upland | California | Recruiting |
| GSK Investigational Site | Gainesville | Florida | Recruiting |
| GSK Investigational Site | Naples | Florida | Recruiting |
| GSK Investigational Site | St Louis | Missouri | Recruiting |
| GSK Investigational Site | New York | New York | Recruiting |
| GSK Investigational Site | New York | New York | Recruiting |
| GSK Investigational Site | New York | New York | Recruiting |
| GSK Investigational Site | Potsdam | New York | Recruiting |
| GSK Investigational Site | Durham | North Carolina | Recruiting |
| GSK Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| GSK Investigational Site | Houston | Texas | Recruiting |
| GSK Investigational Site | Temple | Texas | Recruiting |
| GSK Investigational Site | Salt Lake City | Utah | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | 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 | Córdoba | Argentina | Recruiting |
| GSK Investigational Site | Mendoza | Argentina | Recruiting |
| GSK Investigational Site | Rosario | Argentina | Recruiting |
| GSK Investigational Site | San Miguel de Tucumán | Argentina | Recruiting |
| GSK Investigational Site | Santa Fe | Argentina | Recruiting |
| GSK Investigational Site | Spearwood | Western Australia | Recruiting |
| GSK Investigational Site | Brussels | Belgium | Recruiting |
| GSK Investigational Site | Brussels | Belgium | Recruiting |
| GSK Investigational Site | Liège | Belgium | Recruiting |
| GSK Investigational Site | Namur | Belgium | Recruiting |
| GSK Investigational Site | São José do Rio Preto | São Paulo | Recruiting |
| GSK Investigational Site | Barra Mansa | Brazil | Recruiting |
| GSK Investigational Site | Juiz de Fora | Brazil | Recruiting |
| GSK Investigational Site | Porto Alegre | Brazil | Recruiting |
| GSK Investigational Site | Porto Alegre | Brazil | Recruiting |
| GSK Investigational Site | São Paulo | Brazil | Recruiting |
| GSK Investigational Site | São Paulo | Brazil | Recruiting |
| GSK Investigational Site | Montreal | Quebec | Recruiting |
| GSK Investigational Site | Trois-Rivières | Quebec | Withdrawn |
+ 92 more sites — see the full list on the official registry below.
On this site
📄 Benlysta (belimumab) drug profile →More GlaxoSmithKline trials in Italy
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 NCT06572384 on ClinicalTrials.gov ↗ ← All trials in Italy