🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06669754
Active, not recruiting Phase 3

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

NCT06669754 · tracked via the Priya Life Science UK tracker
Sponsor
Pharvaris Netherlands B.V.
Phase
Phase 3
Started
2024-12-01
Last updated
2026-02-13

Condition(s) studied

Hereditary Angioedema (HAE)

Investigational drug(s) / intervention(s)

DeucrictibantPlacebo

Deucrictibant: Deucrictibant 40mg extended-release tablet for once daily oral use

Placebo: Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Study Site Little Rock Arkansas
Study Site San Diego California
Study site Santa Monica California
Study site Walnut Creek California
Study Site Chevy Chase Maryland
Study Site St Louis Missouri
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 Tokyo Japan
Study Site Auckland New Zealand
Study Site Krakow Poland
Study Site San Juan Puerto Rico
Study Site Sângeorgiu de Mureş Romania
Study Site Singapore Singapore
Study Site Martin Slovakia
Study Site Cape Town South Africa
Study Site Daegu South Korea
Study Site Seoul South Korea
Study Site Seoul South Korea
Study Site Suwon South Korea
Study Site Barcelona Spain
Study Site Barcelona Spain
Study Site Seville Spain

+ 16 more sites — see the full list on the official registry below.

More Pharvaris Netherlands B.V. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06669754 on ClinicalTrials.gov ↗ ← All trials in the UK