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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06679881
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pharvaris Netherlands B.V.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director, Pharvaris
Principal Investigator Affiliation Pharvaris Netherlands B.V.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Bulgaria, Canada, Germany, Hong Kong, Ireland, Italy, Poland, South Korea, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hereditary Angioedema (HAE)
Additional Details

The study consists of a Screening Period during which eligibility is confirmed (only for participants not rolling over within 28 days from a previous deucrictibant prophylactic study), a Treatment Period in which participants will receive open-label deucrictibant extended-release tablet once daily for approximately 130 weeks, followed by an End of Study visit after maximum 4 weeks. Participants will undergo regular safety (e.g. lab draws) and efficacy assessments, will complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.

Arms & Interventions

Arms

Experimental: Deucrictibant

Deucrictibant

Interventions

Drug: - Deucrictibant

Deucrictibant extended-release tablet for once daily oral use

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Study Site, Santa Monica 5393212, California 5332921

Status

Recruiting

Address

Study Site

Santa Monica 5393212, California 5332921, 90404

Study Site, Walnut Creek 5406990, California 5332921

Status

Recruiting

Address

Study Site

Walnut Creek 5406990, California 5332921, 94598

Study Site, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Study Site

St Louis 4407066, Missouri 4398678, 63141

International Sites

Study Site, Melbourne 2158177, Australia

Status

Recruiting

Address

Study Site

Melbourne 2158177, ,

Study Site, Perth 2063523, Australia

Status

Recruiting

Address

Study Site

Perth 2063523, ,

Study Site, Vienna 2761369, Austria

Status

Recruiting

Address

Study Site

Vienna 2761369, ,

Study Site, Sofia 727011, Bulgaria

Status

Recruiting

Address

Study Site

Sofia 727011, ,

Study Site, Montreal 6077243, Canada

Status

Recruiting

Address

Study Site

Montreal 6077243, ,

Study Site, Berlin 2950159, Germany

Status

Recruiting

Address

Study Site

Berlin 2950159, ,

Study Site, Frankfurt 2925536, Germany

Status

Recruiting

Address

Study Site

Frankfurt 2925536, ,

Study Site, Hong Kong 1819729, Hong Kong

Status

Recruiting

Address

Study Site

Hong Kong 1819729, ,

Study Site, Dublin 2964574, Ireland

Status

Recruiting

Address

Study Site

Dublin 2964574, ,

Study Site, Padua 3171728, Italy

Status

Recruiting

Address

Study Site

Padua 3171728, ,

Study Site, Krakow 3094802, Poland

Status

Recruiting

Address

Study Site

Krakow 3094802, ,

Study Site, Daegu 1835329, South Korea

Status

Recruiting

Address

Study Site

Daegu 1835329, ,

Study Site, Seoul 1835848, South Korea

Status

Recruiting

Address

Study Site

Seoul 1835848, ,

Study Site, Barcelona 3128760, Spain

Status

Recruiting

Address

Study Site

Barcelona 3128760, , 08907

Study Site, Brighton 2654710, United Kingdom

Status

Recruiting

Address

Study Site

Brighton 2654710, ,

Study Site, Bristol 2654675, United Kingdom

Status

Recruiting

Address

Study Site

Bristol 2654675, ,

Study Site, Cambridge 2653941, United Kingdom

Status

Recruiting

Address

Study Site

Cambridge 2653941, ,

Study Site, London 2643743, United Kingdom

Status

Recruiting

Address

Study Site

London 2643743, ,

Study Site, Plymouth 2640194, United Kingdom

Status

Recruiting

Address

Study Site

Plymouth 2640194, ,

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