Endpoint | Time point |
Efficacy: primary | |
Annual rate of decline in FVC | Over 52 weeks |
Efficacy: main secondary | |
K-BILD total score | Change from baseline to week 52 |
Time to first acute ILD exacerbation or death | Over 52 weeks |
Time to death | Over 52 weeks |
Efficacy: other secondary | |
Time to death due to respiratory cause | Over 52 weeks |
Time to progression (≥10% absolute decline in FVC % predicted) or death | Over 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 score | Change from baseline to week 52 |
L-PF symptoms, cough domain score | Change from baseline to week 52 |
Safety | |
AEs | Over 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.