Eosinophilic granulomatosis with polyangiitis (EGPA)
Conditions
Brief summary
Primary Efficacy Endpoint: The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0) at Week 28 of the study treatment period., Primary Safety Endpoints: Number of adverse events (AEs) including AEs that may be treatment-related and severe reactions, some of which may be treatment-related.
Detailed description
Secondary Efficacy Endpoints: The proportion of subjects in remission (OGC 7.5) at Week 28 of the study treatment period, Secondary Efficacy Endpoints: Time to first relapse of EGPA (active disease since the last visit after achieved decrease), Secondary Efficacy Endpoints: Time to first worsening of EGPA (worsening of active disease since the last visit)
Interventions
DRUGNS-229 matching tablets with no active treatment
DRUGNS-229
Sponsors
Ns Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0) at Week 28 of the study treatment period., Primary Safety Endpoints: Number of adverse events (AEs) including AEs that may be treatment-related and severe reactions, some of which may be treatment-related. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: The proportion of subjects in remission (OGC 7.5) at Week 28 of the study treatment period, Secondary Efficacy Endpoints: Time to first relapse of EGPA (active disease since the last visit after achieved decrease), Secondary Efficacy Endpoints: Time to first worsening of EGPA (worsening of active disease since the last visit) | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed