Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
| Condition(s) | Hereditary Angioedema (HAE) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema |
| Who can participate | Inclusion Criteria: 1. Provision of the signed ICF by the participant and/or legally designated representative. 2. Male or female, aged ≥12 years at the time of providing written informed consent/assent. 3. Diagnosis of hereditary angioedema (HAE) 4. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening 5. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks. 6. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording. 7. Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods. Exclusion Criteria: 1. Any diagnosis o |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | Pharvaris Netherlands B.V. |
| Locations | Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; San Diego, California, United States; Santa Monica, California, United States; Walnut Creek, California, United States (+56 more sites) |
| Start date | 2025-02-01 |
| NCT ID | NCT06679881 |
| Official listing | https://clinicaltrials.gov/study/NCT06679881 |