Clinical TrialAug 6, 2026, 06:51 AM
Pharvaris Study on AAE-C1INH Informs Phase 3 CREAATE Trial Design
AI Summary
Pharvaris N.V. announced the publication of results from the first in-depth qualitative study assessing the experiences of people with acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH). The study, published in Frontiers in Immunology, provides foundational insights into the disease burden and validates patient-reported outcome measures. These findings directly informed the design and endpoint selection for the company's ongoing Phase 3 CREAATE study, which is investigating deucrictibant for the prophylaxis and on-demand treatment of AAE-C1INH attacks, an ultra-rare condition with no approved therapies.
Key Highlights
- Results from the first in-depth qualitative study on AAE-C1INH published in Frontiers in Immunology.
- Study findings directly informed the design and endpoint selection for the ongoing Phase 3 CREAATE study.
- The Phase 3 CREAATE study (NCT07266805) investigates deucrictibant for AAE-C1INH attacks.
- AAE-C1INH is an ultra-rare disease with no currently approved therapies for prevention or treatment.
- Study confirmed significant patient burden from AAE-C1INH, including misdiagnoses and painful attacks.
- Validated patient-reported outcome (PRO) instruments (PGI-C, PGI-S, PGA) as meaningful for assessing treatment benefits.
- A PGI-C rating of "better" was consistently meaningful within 4 hours post-treatment.
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