RecruitingHereditary Angioedema (HAE)

Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Eligible age

12+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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

Sponsor: Pharvaris Netherlands B.V.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 1. Any diagnosis of angioedema other than HAE
✕ 2. Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at ICF signature (whichever is longer)
✕ 3. Prior gene therapy for any indication at any time
✕ 4. Participants who discontinued from previous studies with deucrictibant prophylactic and/or on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study
✕ 5. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
✕ 6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis
✕ 7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
✕ 8. Abnormal hepatic function