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

Recruiting now · Phase 3

Conditions studied: Hereditary Angioedema (HAE)

In brief

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

Key facts

Study ID

NCT06679881

Run by

Pharvaris Netherlands B.V.

People needed

170

Starts

2025-02-01

Expected to finish

2028-12-01

Last updated by the study team

2026-05-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of the signed ICF by the participant and/or legally designated representative.
• Male or female, aged ≥12 years at the time of providing written informed consent/assent.
• Diagnosis of hereditary angioedema (HAE)
• 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
• Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
• Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
• Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.

You may not qualify if…

• Any diagnosis of angioedema other than HAE
• 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)
• Prior gene therapy for any indication at any time
• 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
• Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
• 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
• Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
• Abnormal hepatic function
• Moderate or severe renal impairment
• Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
• History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
• 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
• Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Where it is running

• Study Site — Scottsdale, Arizona, United States (enrolling)
• Study Site — Little Rock, Arkansas, United States (enrolling)
• Study Site — San Diego, California, United States (enrolling)
• Study Site — Santa Monica, California, United States (enrolling)
• Study Site — Walnut Creek, California, United States (enrolling)
• Study Site — Wheaton, Maryland, United States (enrolling)
• Study Site — St Louis, Missouri, United States (enrolling)
• Study Site — Las Vegas, Nevada, United States (enrolling)
• Study Site — Hershey, Pennsylvania, United States (enrolling)
• Study Site — Dallas, Texas, United States (enrolling)
• Study Site — Milwaukee, Wisconsin, United States (enrolling)
• Study Site — Corrientes, Argentina (enrolling)
• Study Site — Pilar, Argentina (enrolling)
• Study Site — Salta, Argentina (enrolling)
• Study Site — Melbourne, Australia (enrolling)
• Study Site — Melbourne, Australia (enrolling)
• Study Site — Perth, Australia (enrolling)
• Study Site — Sydney, Australia (enrolling)
• Study Site — Vienna, Austria (enrolling)
• Study Site — Ribeirão Preto, Brazil (enrolling)
• Study Site — Salvador, Brazil (enrolling)
• Study Site — Santo André, Brazil (enrolling)
• Study Site — São Paulo, Brazil (enrolling)
• Study Site — São Paulo, Brazil (enrolling)
• Study Site — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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