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Oral medication to prevent angioedema attacks in adolescents and adults

A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

Phase 3 Interventional Pharvaris Netherlands B.V. · NCT06679881

This study is testing a new daily pill to see if it can help prevent angioedema attacks in teenagers and adults with hereditary angioedema.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment170 (estimated)
Ages12 Years and up
SexAll
SponsorPharvaris Netherlands B.V. Industry-sponsored
Locations62 sites (Birmingham, Alabama and 61 other locations)
Trial IDNCT06679881 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, open-label study evaluates the safety and efficacy of once-daily oral deucrictibant extended-release tablets for preventing angioedema attacks in individuals aged 12 and older with hereditary angioedema (HAE). Participants will undergo a screening period to confirm eligibility, followed by approximately 130 weeks of treatment with regular safety and efficacy assessments. They will also maintain an electronic diary to track their condition and complete questionnaires at designated times throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adolescents and adults aged 12 and older diagnosed with hereditary angioedema who have experienced at least one attack in the past three months.

Not a fit: Patients with angioedema not related to hereditary angioedema or those who have participated in other investigational drug studies recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of angioedema attacks for patients with HAE.

How similar studies have performed: Other studies have shown promise with similar prophylactic approaches for hereditary angioedema, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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
9. Moderate or severe renal impairment
10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
12. Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization
13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Where this trial is running

Birmingham, Alabama and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hereditary AngioedemaHAEOral TreatmentBradykinin B2 Receptor AntagonistsPHVS719PHA121DeucrictibantProphylaxis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.