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A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518207-22-00
Acronym
BW-20805-2001
Enrollment
10
Registered
2025-04-07
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Brief summary

Change from baseline in time normalized monthly (per 4 weeks) HAE attack rate over Days 29-169.

Detailed description

Incidence and severity of SAEs and AEs during the main study period, extension study period and whole study., Change from baseline in timenormalized monthly (per 4 weeks) HAE attack rate to Day 169., Change from baseline in time-normalized monthly (per 4 weeks) HAE attack rate during the main study period and extension period., Change from baseline in plasma PKK concentration during the main study period and extension period.

Interventions

DRUGBW-20805 Injection

Sponsors

Shanghai Argo Biopharmaceutical Co. Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in time normalized monthly (per 4 weeks) HAE attack rate over Days 29-169.—

Secondary

MeasureTime frame
Incidence and severity of SAEs and AEs during the main study period, extension study period and whole study., Change from baseline in timenormalized monthly (per 4 weeks) HAE attack rate to Day 169., Change from baseline in time-normalized monthly (per 4 weeks) HAE attack rate during the main study period and extension period., Change from baseline in plasma PKK concentration during the main study period and extension period.—

Countries

Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026