Recruiting
Phase 3

Deucrictibant

Sponsor:

Pharvaris Netherlands B.V.

Code:

NCT06679881

Conditions

Hereditary Angioedema (HAE)

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Deucrictibant

Study Details

Brief 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

Conditions

Hereditary Angioedema (HAE)

Study ID

NCT06679881

Start date

Feb 1, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Deucrictibant

Deucrictibant

Interventions

Deucrictibant

Deucrictibant extended-release tablet for once daily oral use

Primary outcome measure

  • Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation [ Time Frame: 130 weeks ]
  • Change in heart rate [ Time Frame: 130 weeks ]
  • Change in blood pressure [ Time Frame: 130 weeks ]
  • Change in body temperature [ Time Frame: 130 weeks ]
  • Change in clinical laboratory tests from baseline [ Time Frame: 130 weeks ]
  • Change in electrocardiograms (ECGs) from baseline [ Time Frame: 130 weeks ]

Central Contacts and Locations

Central contacts

Locations

Study Site

Recruiting

Birmingham, Alabama, United States, 35209

Study Site

Recruiting

Scottsdale, Arizona, United States, 85251

Study Site

Recruiting

Little Rock, Arkansas, United States, 72205

Study Site

Recruiting

San Diego, California, United States, 92122

Study Site

Recruiting

Santa Monica, California, United States, 90404

Study Site

Recruiting

Walnut Creek, California, United States, 94598

Study Site

Recruiting

Colorado Springs, Colorado, United States, 80907

Study Site

Recruiting

Wheaton, Illinois, United States, 20902

Study Site

Recruiting

St Louis, Missouri, United States, 63141

Study Site

Recruiting

Las Vegas, Nevada, United States, 89128-0450

Study Site

Recruiting

Hershey, Pennsylvania, United States, 17033

Study Site

Recruiting

Dallas, Texas, United States, 75231

Study Site

Recruiting

Milwaukee, Wisconsin, United States, 53226-3067

Study Site

Recruiting

Edmonton, Canada

Study Site

Recruiting

Montreal, Canada

More Information

Sponsor

Pharvaris Netherlands B.V.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • HAE
  • Oral Treatment
  • Bradykinin B2 Receptor Antagonists
  • PHVS719
  • PHA121
  • Deucrictibant
  • Prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pharvaris Netherlands B.V. on 2026-09-01.