Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
Change from baseline in FVC versus placebo up to Week 12 or up to the point of discontinuation
Detailed description
Change from baseline in %FVC up to Week 12, Change from baseline in %DLCO up to Week 12, Change from baseline up to Week 12 in primary and secondary endpoints, Time to first acute exacerbation up to week 12. Change from baseline in KCO and AV up to week 12, Change from baseline in FEV and FEV/FVC ration at week 4,8 and 12. Change from baseline in SF-36, KBKILD and L-PF at weeks 4,8 and 12, Proportion of participants with evidence of disease progression, defined as a decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death.
Interventions
DRUGPlacebo matches MBS2320 Capsules 40mg
DRUGMBS2320
Sponsors
Modern Biosciences Limited, Modern Biosciences Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in FVC versus placebo up to Week 12 or up to the point of discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in %FVC up to Week 12, Change from baseline in %DLCO up to Week 12, Change from baseline up to Week 12 in primary and secondary endpoints, Time to first acute exacerbation up to week 12. Change from baseline in KCO and AV up to week 12, Change from baseline in FEV and FEV/FVC ration at week 4,8 and 12. Change from baseline in SF-36, KBKILD and L-PF at weeks 4,8 and 12, Proportion of participants with evidence of disease progression, defined as a decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death. | — |
Countries
France, Germany, Greece, Hungary, Italy, Spain
Outcome results
None listed