NCT06716606

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)

An Open Label 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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Connective Tissue Diseases

Interventions

Type	Name	Description
DRUG	Belimumab	Belimumab will be administered.

Timeline

• Start date: 2024-12-12
• Primary completion: 2029-12-27
• Completion: 2029-12-27
• First posted: 2024-12-04
• Last updated: 2025-12-09

Locations

10 sites across 7 countries: United States, Argentina, China, Greece, Japan, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study