idiopathic pulmonary fibrosis
Conditions
Brief summary
Change in ppFVC from baseline to Week 24, as compared to PBO.
Detailed description
Absolute change in FVC (mL) from baseline to Week 24, as compared to PBO., Time to disease progression (absolute decline in ppFVC >10%, IPF related hospitalization, or death) up to Week 24, as compared to PBO., Absolute change in L-PF Symptoms Cough domain score from baseline to Week 24, as compared to PBO., Absolute change in L-PF Symptoms Dyspnea domain score from baseline to Week 24, as compared to PBO., Absolute change in L-PF Symptoms Fatigue domain score from baseline to Week 24, as compared to PBO
Interventions
DRUGPlacebo drug product is available as a film-coated tablet containing no taladegib. The dosage form is provided as equivalent in size
DRUGcolor and shape to the active 25 mg oval-shaped
DRUGconvex
DRUGaquamarine-colored tablets.
DRUGTaladegib
DRUGPlacebo drug product is available as a film-coated tablet containing no taladegib. the dosage form is provided as equivalent in size
DRUGcolor and shape to the active 100 mg oval-shaped
Sponsors
Endeavor Biomedicines Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in FVC (mL) from baseline to Week 24, as compared to PBO., Time to disease progression (absolute decline in ppFVC >10%, IPF related hospitalization, or death) up to Week 24, as compared to PBO., Absolute change in L-PF Symptoms Cough domain score from baseline to Week 24, as compared to PBO., Absolute change in L-PF Symptoms Dyspnea domain score from baseline to Week 24, as compared to PBO., Absolute change in L-PF Symptoms Fatigue domain score from baseline to Week 24, as compared to PBO | — |
Primary
| Measure | Time frame |
|---|---|
| Change in ppFVC from baseline to Week 24, as compared to PBO. | — |
Countries
Austria, Belgium, France, Germany, Ireland, Italy
Outcome results
None listed