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Oral medication to prevent angioedema attacks in adolescents and adults with HAE

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety 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. · NCT06669754

This study is testing a new oral medication to see if it can help prevent angioedema attacks in adolescents and adults with hereditary angioedema.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment81 (estimated)
Ages12 Years and up
SexAll
SponsorPharvaris Netherlands B.V. Industry-sponsored
Locations22 sites (Little Rock, Arkansas and 21 other locations)
Trial IDNCT06669754 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy and safety of deucrictibant, an oral extended-release tablet, for preventing angioedema attacks in individuals aged 12 and older diagnosed with hereditary angioedema (HAE). Participants will be randomly assigned to receive either the active medication or a placebo for a 24-week treatment period, followed by a maximum 4-week follow-up. Throughout the study, participants will complete daily electronic diaries and questionnaires to monitor their health and treatment effects. The study aims to confirm the medication's effectiveness compared to placebo in reducing the frequency of angioedema attacks.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 12 years and older with a confirmed diagnosis of hereditary angioedema and a history of frequent attacks.

Not a fit: Patients with angioedema not caused by hereditary factors or those who have recently participated in other clinical trials may not benefit from this study.

Why it matters

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

How similar studies have performed: Previous studies have shown promise with similar approaches in managing hereditary angioedema, indicating potential for success with this treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Provision of written informed consent/assent.
2. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
3. Diagnosis of hereditary angioedema (HAE)
4. History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
5. Predefined number of attacks during the Screening Period
6. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
7. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
8. Female participants of childbearing potential 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 Screening (whichever is longer)
3. Has received prior prophylactic treatment with deucrictibant
4. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
5. Prior gene therapy for any indication at any time
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

Little Rock, Arkansas and 21 other locations

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.