Hereditary Angioedema
Conditions
Brief summary
Incidence of adverse events (AEs)
Detailed description
Change from baseline in monthly HAE attack rate, Incidence of monthly HAE attack severity (mild, moderate, and severe), Duration of monthly HAE attack (shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours), The number of monthly HAE attacks requiring on-demand therapy, Time to first HAE attack after each dose, Number of HAE attack-free days, Proportion of HAE attack-free participants (i.e., participants having 0 HAE attacks during the specified treatment period), Concentration of STAR-0215 and the derived PK parameters, Change in plasma kallikrein activity, Formation of anti-drug (STAR-0215) antibodies
Interventions
DRUGNavenibart
Sponsors
Astria Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in monthly HAE attack rate, Incidence of monthly HAE attack severity (mild, moderate, and severe), Duration of monthly HAE attack (shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours), The number of monthly HAE attacks requiring on-demand therapy, Time to first HAE attack after each dose, Number of HAE attack-free days, Proportion of HAE attack-free participants (i.e., participants having 0 HAE attacks during the specified treatment period), Concentration of STAR-0215 and the derived PK parameters, Change in plasma kallikrein activity, Formation of anti-drug (STAR-0215) antibodies | — |
Countries
Bulgaria, Czechia, Germany, Poland
Outcome results
None listed