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Clinical Trials in Germany / NCT06679881
Enrolling by invitation Phase 3

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

NCT06679881 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-02-01
Last updated
2026-09-22

Condition(s) studied

Hereditary Angioedema (HAE)

Investigational drug(s) / intervention(s)

Deucrictibant →

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

Study 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

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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 the participant being capable of and compliant with data recording into an eDiary. 7. Female participants of childbearing age 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 angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) 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 enrollment. 13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
Study Site Birmingham Alabama
Study Site Scottsdale Arizona
Study Site Little Rock Arkansas
Study Site San Diego California
Study Site Santa Monica California
Study Site Walnut Creek California
Study Site Colorado Springs Colorado
Study Site Wheaton Illinois
Study Site St Louis Missouri
Study Site Las Vegas Nevada
Study Site Hershey Pennsylvania
Study Site Dallas Texas
Study Site Milwaukee Wisconsin
Study Site Corrientes Argentina
Study Site Pilar Argentina
Study Site Salta Argentina
Study Site Box Hill Australia
Study Site Parkville Australia
Study Site Perth Australia
Study Site Sydney Australia
Study Site Vienna Austria
Study Site Ribeirão Preto Brazil
Study Site Salvador Brazil
Study Site Santo André Brazil
Study Site São Paulo Brazil
Study Site São Paulo Brazil
Study Site Sofia Bulgaria
Study Site Edmonton Canada
Study Site Montreal Canada
Study Site Beijing China
Study Site Grenoble France
Study Site Berlin Germany
Study Site Frankfurt Germany
Study Site Munich 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 Palermo Italy

+ 27 more sites — see the full list on the official registry below.

More Pharvaris Netherlands B.V. trials in Germany

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 NCT06679881 on ClinicalTrials.gov ↗ ← All trials in Germany