Deucrictibant: Deucrictibant 40mg extended-release tablet for once daily oral use
Placebo: Placebo
Study summary
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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period — 24 weeks
Trial sites (56)
Facility
City
Region
Status
Study Site
Little Rock
Arkansas
Study Site
San Diego
California
Study site
Santa Monica
California
Study site
Walnut Creek
California
Study Site
Chevy Chase
Maryland
Study Site
St Louis
Missouri
Study Site
Corrientes
Argentina
Study Site
San Martin
Argentina
Study Site
Santo André
Brazil
Study Site
Sofia
Bulgaria
Study Site
Sofia
Bulgaria
Study Site
Edmonton
Canada
Study Site
Ottawa
Canada
Study Site
Grenoble
France
Study Site
Lille
France
Study Site
Berlin
Germany
Study Site
Frankfurt
Germany
Study Site
Hanover
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
Kawasaki
Japan
Study Site
Tokyo
Japan
Study Site
Tokyo
Japan
Study Site
Auckland
New Zealand
Study Site
Krakow
Poland
Study Site
San Juan
Puerto Rico
Study Site
Sângeorgiu de Mureş
Romania
Study Site
Singapore
Singapore
Study Site
Martin
Slovakia
Study Site
Cape Town
South Africa
Study Site
Daegu
South Korea
Study Site
Seoul
South Korea
Study Site
Seoul
South Korea
Study Site
Suwon
South Korea
Study Site
Barcelona
Spain
Study Site
Barcelona
Spain
Study Site
Seville
Spain
+ 16 more sites — see the full list on the official registry below.
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.
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