Full name

An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

NCT Number
NCT06716606
Primary Endpoints

Primary:

  • Number of participants with Adverse events (AEs), Adverse Event of Special Interest events (AESIs), and Serious Adverse Event (SAEs). Up to approximately 5 years

Secondary:

  • Change from Baseline in Forced Vital Capacity (FVC). Baseline (Day 1 of OLE study) and at Weeks 12, 26, 52, 104, 156, 208 and 260
Order
2
Disease
SSc-ILD
Menu title
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Version
ASN 2025
Phase
3
Status
Recruiting
Compound name
Belimumab
MoA
anti-BLyS mAb
Unmet Burden Fact
  • Incidence of SSc is 10–50 cases per million people per year
  • ILD is a leading cause of morbidity and mortality in patients with SSc, with a 10-year mortality of 40%
Unmet Burden Fact Reference

Perelas A, et al. Lancet Respir Med. 2020;8:304–320

Study Description

This is an open label extension (OLE) study of an ongoing randomized controlled clinical study 218224 (Parent Study). 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.