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NCT06679881PHASE3Recruiting

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

Pharvaris Netherlands B.V.

Start Date

2/1/2025

Completion Date

12/1/2028

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

Detailed Description

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.

Eligibility Criteria

Age Range: 12 years to No maximum

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 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

Interventions

DRUG

Deucrictibant

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Conditions

Hereditary Angioedema (HAE)

Locations

Study Site

Birmingham, Alabama 35209

United States

Study Site

Scottsdale, Arizona 85251

United States

Study Site

Little Rock, Arkansas 72205

United States

Study Site

San Diego, California 92122

United States

Study Site

Santa Monica, California 90404

United States

Study Site

Walnut Creek, California 94598

United States

Study Site

Wheaton, Maryland 20902

United States

Study Site

St Louis, Missouri 63141

United States

Study Site

Las Vegas, Nevada 89128-0450

United States

Study Site

Hershey, Pennsylvania 17033

United States

Study Site

Dallas, Texas 75231

United States

Study Site

Milwaukee, Wisconsin 53226-3067

United States

Study Site

Corrientes,

Argentina

Study Site

Pilar,

Argentina

Study Site

Salta,

Argentina

Study Site

Melbourne, 3052

Australia

Study Site

Melbourne,

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, 01454010

Brazil

Study Site

São Paulo, 14051-140

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

Padova,

Italy

Study Site

Palermo,

Italy

Study Site

Roma,

Italy

Study Site

Hiroshima,

Japan

Study Site

Kanagawa,

Japan

Study Site

Osaka,

Japan

Study Site

Tokyo,

Japan

Study Site

Krakow,

Poland

Study Site

Martin,

Slovakia

Study Site

Cape Town,

South Africa

Study Site

Daegu,

South Korea

Study Site

Seoul,

South Korea

Study Site

Barcelona, 08907

Spain

Study Site

Ankara,

Turkey (Türkiye)

Study Site

Istanbul,

Turkey (Türkiye)

Study Site

Izmir,

Turkey (Türkiye)

Study Site

Birmingham, B18 7QH

United Kingdom

Study Site

Birmingham, B9 5SS

United Kingdom

Study Site

Brighton,

United Kingdom

Study Site

Bristol,

United Kingdom

Study Site

Cambridge,

United Kingdom

Study Site

London, E1 1FR

United Kingdom

Study Site

London,

United Kingdom

Study Site

Oxford,

United Kingdom

Study Site

Plymouth,

United Kingdom

Study Site

Southampton,

United Kingdom