A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)
GlaxoSmithKline
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent. 2. Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria. 3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \>0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1. 4. Total mRSS ≥15 on Day 1. 5. Evidence of interstitial lung disease on centrally read screening HRCT. 6. Anticentromere antibody negat…
Interventions
- BiologicalBelimumab
Belimumab will be administered.
- OtherPlacebo
.Placebo will be administered.
Locations (131)
- GSK Investigational SitePhoenix, Arizona
- GSK Investigational SiteScottsdale, Arizona
- GSK Investigational SiteScottsdale, Arizona
- GSK Investigational SiteTucson, Arizona
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteLos Angeles, California