AN OPEN LABEL, SINGLE ARM, EXPLORATIVE TRIAL TO EVALUATE EFFICACY AND SAFETY OF BEROTRALSTAT IN PREVENTING ANGIOEDEMA ATTACKS IN SUBJECTS WITH ACQUIRED ANGIOEDEMA DUE TO C1 INHIBITOR DEFICIENCY (AAE)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524747-13-00

Enrollment

Registered

2026-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-12

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

Conditions

Acquired angioedema due to C1 inhibitor deficiency

Brief summary

the change in the monthly HAE attacks rate, from week 1 to week 24 month of treatment compared to attack rate during the run-in period

Detailed description

- monthly HAE attacks rate over 6 months of treatment - rate of attacks requiring rescue treatment - attack free period - the proportion of days without angioedema symptoms - proportion of attack rated mile, moderate or severe

Interventions

DRUGOrladeyo 150 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
the change in the monthly HAE attacks rate, from week 1 to week 24 month of treatment compared to attack rate during the run-in period	—

Secondary

Measure	Time frame
- monthly HAE attacks rate over 6 months of treatment - rate of attacks requiring rescue treatment - attack free period - the proportion of days without angioedema symptoms - proportion of attack rated mile, moderate or severe	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 13, 2026