NCT06572384

A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
BIOLOGICAL	Belimumab	Belimumab will be administered.
OTHER	Placebo	Placebo will be administered.

Timeline

• Start date: 2024-09-11
• Primary completion: 2028-10-18
• Completion: 2028-12-13
• First posted: 2024-08-27
• Last updated: 2026-03-03

Locations

131 sites across 18 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Italy, Japan, Mexico, Netherlands, Panama, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study