Idiopathic Pulmonary Fibrosis (IPF)
Conditions
Brief summary
Change in FVC (mL) from Baseline to Week 26
Detailed description
•The percentage of subjects (%) with Treatment Emergent Adverse Events (TEAE), • Relative change in FVC (mL) from Baseline to Week 26, • Absolute change and relative change in percent predicted FVC (ppFVC) (%) from Baseline to Week 26, • Proportion of participants with a ≥ 10% absolute decline in ppFVC (%) at Week 12 and 26 from Baseline, • Time to first ≥ 10% absolute decline in ppFVC (%), • Change in quantitative CT-derived lung fibrosis burden on HRCT
Interventions
DRUGPIPE-791
DRUGPlacebo to PIPE-791
Sponsors
Contineum Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FVC (mL) from Baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| •The percentage of subjects (%) with Treatment Emergent Adverse Events (TEAE), • Relative change in FVC (mL) from Baseline to Week 26, • Absolute change and relative change in percent predicted FVC (ppFVC) (%) from Baseline to Week 26, • Proportion of participants with a ≥ 10% absolute decline in ppFVC (%) at Week 12 and 26 from Baseline, • Time to first ≥ 10% absolute decline in ppFVC (%), • Change in quantitative CT-derived lung fibrosis burden on HRCT | — |
Outcome results
None listed