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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

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

Sundberg Aimee

Clinical Development

J.H. Oortweg 21, 2333 CH Leiden, Netherlands

clinicaltrials@pharvaris.com

Maeno Akane

A2 Healthcare Corporation

Sumitomo Fudosan Korakuen Bldg, 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

+81-3-3830-1173

chapter-3_trialinfomation@a2healthcare.com

Not Recruiting

Mar. 25, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1. Provision of written informed consent/assent.
2. Male or female, aged 12 years and older at the time of providing written informed consent/assent.
3. Diagnosis of hereditary angioedema (HAE) type 1/2
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 a highly effective contraception methods as available locally.

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 or on-demand treatment with deucrictibant, with the exception of participants from Study PHA022121-C306
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

Both

Hereditary Angioedema

Deucrictibant 40mg extended-release tablet by mouth once daily for 24 weeks.

Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period.

+81-3-3813-3111

Feb. 28, 2025

No

UK/Ireland/France/Germany/Switzerland/Italy/Spain/Poland/Sweden/South Africa/Qatar/Saudi Arabia/Bulgaria/Turkey/Hungary/Romania/Slovakia/New Zealand/South Korea/Hong Kong/China/Singapore/USA/Canad/Colombia/Brazil/Argentina/Puerto Rico