drugset / Trial / NCT05878717

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

NCT05878717

Phase 2/3 Recruiting 300 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Timeline

Start
2023-09-13
Primary completion
2029-05-17
Completion
2029-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody Subcutaneous