Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
1 other identifier
interventional
90
18 countries
47
Brief Summary
Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2026
Typical duration for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
April 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
June 16, 2026
June 1, 2026
4.2 years
February 19, 2026
June 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of ADX-324 in Participants with HAE
Incidence and severity of treatment-emergent adverse events
Month 36
Secondary Outcomes (1)
Efficacy of ADX-324 in Preventing HAE Attacks
Month 36
Study Arms (2)
ADX-324 Dose Level 1
EXPERIMENTALADX-324 Dose Level 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have a documented diagnosis of HAE (Type I or II)
- Completed Study ADX-324-301
- Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)
You may not qualify if:
- A negative reaction to study drug in ADX-324-301
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
ADARx Clinical Site
Litchfield Park, Arizona, 85340, United States
ADARx Clinical Site
Little Rock, Arkansas, 72205, United States
ADARx Clinical Site
San Diego, California, 92122, United States
ADARx Clinical Site
Walnut Creek, California, 94598, United States
ADARx Clinical Site
Orlando, Florida, 32807, United States
ADARx Clinical Site
Chevy Chase, Maryland, 20815, United States
ADARx Clinical Site
Wheaton, Maryland, 20902, United States
ADARx Clinical Site
Detroit, Michigan, 48202, United States
ADARx Clinical Site
St Louis, Missouri, 63141, United States
ADARx Clinical Site
Las Vegas, Nevada, 89128, United States
ADARx Clinical Site
New York, New York, 10029, United States
ADARx Clinical Site
Cincinnati, Ohio, 45236, United States
ADARx Clinical Site
Columbus, Ohio, 43235, United States
ADARx Clinical Site
Toledo, Ohio, 43617, United States
ADARx Clinical Site
Hershey, Pennsylvania, 17033, United States
ADARx Clinical Site
Capital Federal, Buenos Aires, C1425BEN, Argentina
ADARx Clinical Site
Buenos Aires, Buenos Aires F.D., C1035AAT, Argentina
ADARx Clinical Site
Adelaide, South Australia, 5000, Australia
ADARx Clinical Site
Vienna, 1090, Austria
ADARx Clinical Site
Edegem, Antwerpen, 2650, Belgium
ADARx Clinical Site
Sofia, 1000, Bulgaria
ADARx Clinical Site
Edmonton, Alberta, T6G 2R3, Canada
ADARx Clinical Site
Ottawa, Ontario, K1H 1E4, Canada
ADARx Clinical Site
Montreal, Quebec, H2W 1R7, Canada
ADARx Clinical Site
Beijing, 100730, China
ADARx Clinical Site
Harbin, 150001, China
ADARx Clinical Site
Zhengzhou, 450003, China
ADARx Clinical Site
Split, 21000, Croatia
ADARx Clinical Site
Zagreb, 10000, Croatia
ADARx Clinical Site
Hradec Králové, 500 05, Czechia
ADARx Clinical Site
Prague, 15000, Czechia
ADARx Clinical Site
Nice, Alpes-Maritimes, 06300, France
ADARx Clinical Site
Tours, Indre-et-Loire, 37000, France
ADARx Clinical Site
Montpellier, 34295, France
ADARx Clinical Site
Paris, 75012, France
ADARx Clinical Site
Tübingen, Baden-Wurttemberg, 72076, Germany
ADARx Clinical Site
Hong Kong, 111, Hong Kong
ADARx Clinical Site
Budapest, 1088, Hungary
ADARx Clinical Site
Ashkelon, 7830604, Israel
ADARx Clinical Site
Tel Aviv, 5262100, Israel
ADARx Clinical Site
Lodz, 92-213, Poland
ADARx Clinical Site
Barcelona, 08907, Spain
ADARx Clinical Site
Madrid, 28007, Spain
ADARx Clinical Site
Taichung, 40705, Taiwan
ADARx Clinical Site
Cambridge, CB2 0QQ, United Kingdom
ADARx Clinical Site
Cardiff, CF14 4YS, United Kingdom
ADARx Clinical Site
London, E1 1BB, United Kingdom
ADARx Clinical Site
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lauge Farnaes, MD
ADARx Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 23, 2026
Study Start
April 2, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
June 16, 2026
Record last verified: 2026-06