Phase 23 Study of Belimumab Given by Injection for Adults with Systemic Sclerosis and Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, both given alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease SSc-ILD. The study aims to assess how belimumab affects lung function, skin thickening, and symptoms like fatigue that influence quality of life in these patients. This is a Phase 23 randomized, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be randomly assigned to receive either belimumab or a placebo, both administered subcutaneously along with standard therapy. The treatment period lasts 52 weeks, during which the effects on lung function and skin symptoms will be closely monitored. The study involves two groups one receiving belimumab plus standard care and the other receiving placebo plus standard care. During the study, participants will undergo assessments including lung function tests such as Forced Vital Capacity FVC, skin thickness scoring, fatigue evaluations, and quality of life questionnaires at baseline and Week 52. Researchers will also track any adverse events and serious side effects. The main outcome measured is the change in lung function after 52 weeks. Participants will be monitored regularly throughout the 52-week treatment period to evaluate treatment effects and safety.

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease