Table 2

Study endpoints

EndpointTime point
Efficacy: primary
 Annual rate of decline in FVCOver 52 weeks
Efficacy: main secondary
 K-BILD total scoreChange from baseline to week 52
 Time to first acute ILD exacerbation or deathOver 52 weeks
 Time to deathOver 52 weeks
Efficacy: other secondary
 Time to death due to respiratory causeOver 52 weeks
 Time to progression (≥10% absolute decline in FVC % predicted) or deathOver 52 weeks
 Proportion of patients with a relative decline in FVC % predicted of >10%Baseline to week 52
 Proportion of patients with a relative decline in FVC % predicted of >5%Baseline to week 52
 L-PF symptoms, dyspnoea domain scoreChange from baseline to week 52
 L-PF symptoms, cough domain scoreChange from baseline to week 52
Safety
 AEsOver 52 weeks*
 Physical examination
 Vital signs
 Body weight
  • Clinical laboratory tests.

  • *Primary safety assessment—selected safety analyses will be repeated to include data collected beyond 52 weeks (part B of the study).

  • AE, adverse event; FVC, forced vital capacity; ILD, interstitial lung disease; K-BILD; King’s Brief Interstitial Lung Disease Questionnaire; L-PF, living with pulmonary fibrosis.