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A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521142-22-00
Enrollment
17
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-10

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

Conditions

Hereditary Angioedema

Brief summary

Incidence of treatment-emergent adverse events

Detailed description

Number of time-normalized investigator-confirmed HAE attacks, Number of moderate or severe investigator-confirmed HAE attacks, Number of investigator-confirmed HAE attacks that require on-demand treatment, Percent reduction in monthly investigator-confirmed HAE attacks, Time to first investigator-confirmed HAE attack after first dose, The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate, Number of participants with no investigator-confirmed HAE attacks, Angioedema Quality of Life (AE-QoL) questionnaire total score

Interventions

Sponsors

Astria Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of treatment-emergent adverse events

Secondary

MeasureTime frame
Number of time-normalized investigator-confirmed HAE attacks, Number of moderate or severe investigator-confirmed HAE attacks, Number of investigator-confirmed HAE attacks that require on-demand treatment, Percent reduction in monthly investigator-confirmed HAE attacks, Time to first investigator-confirmed HAE attack after first dose, The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate, Number of participants with no investigator-confirmed HAE attacks, Angioedema Quality of Life (AE-QoL) questionnaire total score

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 11, 2026