OBJECTIVES: Nintedanib is a tyrosine kinase inhibitor approved for the treatment 
of idiopathic pulmonary fibrosis (IPF). The pathological pathways involved in 
fibrogenesis in IPF and interstitial lung disease associated with systemic 
sclerosis (SSc-ILD) show commonalities; both involve fibroblast activation, 
myofibroblast accumulation and deposition of extracellular matrix. The SENSCIS™ 
trial is a randomised, placebo-controlled Phase III trial that will evaluate the 
efficacy and safety of nintedanib in patients with SSc-ILD (NCT02597933).
METHODS: Approximately 520 patients with SSc (based on 2013 American College of 
Rheumatology/European League Against Rheumatism criteria) and ILD (≥10% fibrosis 
of the lungs, confirmed by central assessment of chest high resolution computed 
tomography), forced vital capacity (FVC) ≥40% predicted and diffusing capacity 
for carbon monoxide of 30-89% predicted will be enrolled. Patients will be 
randomised (1:1) to nintedanib 150 mg twice daily or placebo, stratified by the 
presence of anti-topoisomerase I antibody. To reflect real-world management, 
patients receiving prednisone (≤10 mg/day) and/or a stable dose of mycophenolate 
or methotrexate, will be eligible. The primary endpoint is the annual rate of 
decline in FVC (mL/ year) assessed over 52 weeks. Patients will remain on 
blinded study treatment until the last patient completes 52 weeks of treatment 
or for a maximum of 100 weeks of treatment. Key secondary endpoints are absolute 
changes from baseline in modified Rodnan skin score and St George's Respiratory 
Questionnaire at week 52.
RESULTS: Recruitment for the trial began in November 2015.
CONCLUSIONS: This trial will assess the efficacy and safety of nintedanib in 
patients with SSc-ILD.