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, 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.

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. 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

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.	NCT06669754
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	Argentina, Brazil, Bulgaria, Canada, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, New Zealand, Poland, Puerto Rico, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), 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, a Treatment Period of 24 weeks, and a Follow-up Period of maximum 4 weeks or subjects may roll over into the open-label study PHA022121-C307 (CHAPTER-4). During the Treatment period participants will receive blinded study drug (deucrictibant or placebo randomized in a 2:1 ratio). Participants will undergo regular efficacy and safety assessments, complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.

Arms & Interventions

Arms

Experimental: Active

Deucrictibant 40mg extended-release tablet by mouth once daily

Experimental: Placebo

Placebo 1 tablet by mouth once daily

Interventions

Drug: - Deucrictibant

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

Drug: - Placebo

Placebo

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, Little Rock 4119403, Arkansas 4099753

Status

Recruiting

Address

Study Site

Little Rock 4119403, Arkansas 4099753, 72205

Site Contact

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