Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
Core Phase: Change in FVC % predicted from Baseline to Week 52. Extension Phase: Change from both Baselines in FVC % predicted at Week 104.
Detailed description
Core Phase: 1. Proportion of subjects with decline in FVC % predicted ≥10% from Baseline at Week 52. 2. Change from Baseline in the 6MWT results to Week 52. 3. Change from Baseline in K-BILD scores to Week 52. 4. Change from Baseline in L-IPF scores to Week 52. 5. Change from Baseline in LCQ scores to Week 52. Please refer to protocol section 8.1.2 and 8.2.2 for details
Interventions
Sponsors
Horizon Therapeutics Ireland Designated Activity Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core Phase: Change in FVC % predicted from Baseline to Week 52. Extension Phase: Change from both Baselines in FVC % predicted at Week 104. | — |
Secondary
| Measure | Time frame |
|---|---|
| Core Phase: 1. Proportion of subjects with decline in FVC % predicted ≥10% from Baseline at Week 52. 2. Change from Baseline in the 6MWT results to Week 52. 3. Change from Baseline in K-BILD scores to Week 52. 4. Change from Baseline in L-IPF scores to Week 52. 5. Change from Baseline in LCQ scores to Week 52. Please refer to protocol section 8.1.2 and 8.2.2 for details | — |
Countries
France, Greece, Italy, Netherlands, Poland, Spain
Outcome results
None listed