Lung transplant rejection
Conditions
Brief summary
Percent change from baseline to Week 26 in FEV1
Detailed description
Response rate at Week 26. Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline, Absolute change from baseline to Week 26 in FEV1, Absolute change from baseline to Week 26 in percent predicted FEV1, Percent change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in percent predicted FVC, Time to CLAD progression during the doubleblind treatment period.Defined as the first of the following events: >10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death., Time to re-transplantation or death, Percent change from baseline to Week 26 in 6- minute walk distance, Absolute change from baseline to Week 26 in 6-minute walk distance, Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ). Total score and scores by domain, Change from baseline to Week 26 in EQ-5D-5L.Visual analogue scale and individual dimensions, Change from baseline to Week 26 in Patient- Reported Outcomes Measurement Information System-29 profile version 2.1. PROMIS-29 profile V2.1 (domain scores), Number of participants with adverse events (AEs) and serious adverse events (SAEs). Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Week 26 in FEV1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate at Week 26. Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline, Absolute change from baseline to Week 26 in FEV1, Absolute change from baseline to Week 26 in percent predicted FEV1, Percent change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in percent predicted FVC, Time to CLAD progression during the doubleblind treatment period.Defined as the first of the following events: >10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death., Time to re-transplantation or death, Percent change from baseline to Week 26 in 6- minute walk distance, Absolute change from baseline to Week 26 in 6-minute walk distance, Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ). Total score and scores by domain, Change from baseline to Week 26 in EQ-5D-5L.Visual analogue scale and individual dime | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden