Endpoints in the INMARK® trial
| Primary endpoint | Rate of change in serum CRPM from baseline to week 12 |
| Key secondary endpoint | Proportion of patients with absolute decline in FVC ≥10% predicted or who died over 52 weeks |
| Secondary endpoints | Rate of change in serum C1M from baseline to week 12 |
| Rate of change in serum C3M from baseline to week 12 | |
| Further endpoints | Rate of change in serum CRPM from week 12 to week 52 |
| Rate of change in serum C1M from week 12 to week 52 | |
| Rate of change in serum C3M from week 12 to week 52 | |
| Rate of change in serum BGM from baseline to week 12 | |
| Rate of change in serum C3A from baseline to week 12 | |
| Rate of change in serum C5M from baseline to week 12 | |
| Rate of change in serum C6M from baseline to week 12 | |
| Rate of change in serum VICM from baseline to week 12 | |
| Rate of change in serum BGM from week 12 to week 52 | |
| Rate of change in serum C3A from week 12 to week 52 | |
| Rate of change in serum C5M from week 12 to week 52 | |
| Rate of change in serum C6M from week 12 to week 52 | |
| Rate of change in serum VICM from week 12 to week 52 | |
| Proportion of patients with absolute decline in FVC ≥5% predicted over 52 weeks | |
| Proportion of patients with absolute decline in FVC ≥10% predicted over 52 weeks | |
| Proportion of patients who had absolute decline in FVC ≥5% predicted or who died over 52 weeks | |
| Time to decline in FVC ≥5% predicted over 52 weeks | |
| Time to decline in FVC ≥10% predicted over 52 weeks | |
| Time to decline in FVC ≥5% predicted or death over 52 weeks | |
| Time to decline in FVC ≥10% predicted or death over 52 weeks | |
| Annual rate of decline in FVC (mL/year) | |
| Absolute change from baseline in FVC % predicted at week 52 | |
| Absolute change from baseline in FVC (mL) at week 52 | |
| Relative change from baseline in FVC (% predicted) at week 52 | |
| Relative change from baseline in FVC (mL) at week 52 | |
| Annual rate of decline in FEV6 (mL/year) based on home spirometry | |
| Annual rate of decline in FVC (mL/year) based on home spirometry | |
| Time to first acute exacerbation over 52 weeks | |
| Change from baseline in SGRQ total score over 52 weeks | |
| Change from baseline in UCSD-SOBQ over 52 weeks | |
| Predose plasma concentrations of nintedanib and its metabolites (BIBF 1202 and BIBF 1202-glucuronide) |
All spirometry endpoints are based on clinic assessments unless otherwise stated.
BGM, biglycan degraded by MMP-2/9; CRPM, C reactive protein degraded by MMP-1/8; C1M, collagen 1 degraded by MMP; C3A, collagen 3 degraded by ADAMTS-1/4/8; C3M, collagen 3 degraded by MMP-9; C5M, collagen 5 degraded by MMP-2/9; C6M, collagen 6 degraded by MMP-2/9; FEV6, forced expiratory volume in 6 s; FVC, forced vital capacity; MMP, metalloproteinase; SGRQ, St. George’s Respiratory Questionnaire; UCSD-SOBQ, University of California San Diego Shortness of Breath Questionnaire; VICM, citrullinated vimentin degraded by MMP-2/8.