chronic pulmonary sarcoidosis
Conditions
Brief summary
Proportion of subjects with a rescue event during DB period.
Detailed description
Change from baseline in percent predicted forced vital capacity (ppFVC) at Week 26;, Time to first rescue event during DB period;, Proportion of subjects successfully achieving OCS taper without rescue event during DB period;, Change from baseline in the KSQ Lung domain score at Week 26;, Safety and tolerability, including assessment of physical examinations (PEs), vital signs, electrocardiograms (ECGs), clinical laboratory measurements, and AEs during DB period;
Interventions
DRUGplacebo
DRUGNamilumab
Sponsors
Kinevant Sciences GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a rescue event during DB period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in percent predicted forced vital capacity (ppFVC) at Week 26;, Time to first rescue event during DB period;, Proportion of subjects successfully achieving OCS taper without rescue event during DB period;, Change from baseline in the KSQ Lung domain score at Week 26;, Safety and tolerability, including assessment of physical examinations (PEs), vital signs, electrocardiograms (ECGs), clinical laboratory measurements, and AEs during DB period; | — |
Countries
Belgium, France, Germany, Netherlands
Outcome results
None listed