Idiopathic pulmonary fibrosis
Conditions
Brief summary
The annualized rate of decline in morning pre dose trough forced vital capacity (FVC) (mL) over 26 weeks
Detailed description
Time to disease progression. Disease progression is defined as absolute FVC percent predicted decline of ≥10%, or occurrence of lung transplant or all-cause death prior to Week 26., The annualized rate of decline in FVC percent predicted over 26 weeks., Change in St. George’s Respiratory Questionnaire (SGRQ) from baseline to Week 26., The mean change in diffusion capacity for carbon monoxide (DLCO % of predicted, corrected for hemoglobin) from baseline to Week 26.
Interventions
DRUGPlacebo
DRUGAXATILIMAB
Sponsors
Syndax Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annualized rate of decline in morning pre dose trough forced vital capacity (FVC) (mL) over 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression. Disease progression is defined as absolute FVC percent predicted decline of ≥10%, or occurrence of lung transplant or all-cause death prior to Week 26., The annualized rate of decline in FVC percent predicted over 26 weeks., Change in St. George’s Respiratory Questionnaire (SGRQ) from baseline to Week 26., The mean change in diffusion capacity for carbon monoxide (DLCO % of predicted, corrected for hemoglobin) from baseline to Week 26. | — |
Countries
Belgium, Czechia, France, Germany, Italy, Poland, Romania, Spain
Outcome results
None listed