Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema (HAE)

In brief

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.

Key facts

Study ID

NCT06669754

Run by

Pharvaris Netherlands B.V.

People needed

81

Starts

2024-12-01

Expected to finish

2026-08-01

Last updated by the study team

2026-02-13

Who can join

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

You may qualify if…

• Provision of written informed consent/assent.
• Male or female, aged ≥12 years at the time of providing written informed consent/assent.
• Diagnosis of hereditary angioedema (HAE)
• History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
• Predefined number of attacks during the Screening Period
• 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 potential 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 Screening (whichever is longer)
• Has received prior prophylactic treatment with deucrictibant
• Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
• Prior gene therapy for any indication at any time
• 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 — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Walnut Creek, California, United States
• Study Site — Chevy Chase, Maryland, United States
• Study Site — St Louis, Missouri, United States
• Study Site — Corrientes, Argentina
• Study Site — San Martin, Argentina
• Study Site — Santo André, Brazil
• Study Site — Sofia, Bulgaria
• Study Site — Sofia, Bulgaria
• Study Site — Edmonton, Canada
• Study Site — Ottawa, Canada
• Study Site — Grenoble, France
• Study Site — Lille, France
• Study Site — Berlin, Germany
• Study Site — Frankfurt, Germany
• Study Site — Hanover, Germany
• Study Site — Hong Kong, Hong Kong
• Study Site — Budapest, Hungary
• Study Site — Dublin, Ireland
• Study Site — Milan, Italy
• Study Site — Padova, Italy
• Study Site — Kawasaki, Japan
• Study Site — Tokyo, Japan
• Study Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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