What this study is
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.
What's being tested
- ADX-324 Dose Level 1
Intervention · DRUG
- ADX-324 Dose Level 2
Intervention · DRUG
Both interventions
siRNA duplex oligonucleotide
Study details
- Official title
- A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
- Sponsor
- ADARx Pharmaceuticals, Inc.
- Conditions
- Hereditary Angioedema (HAE) · Hereditary Angioedema - Type 1 · Hereditary Angioedema - Type 2 · HAE
- Enrolling
- 90 people
- Starts
- 2026-04-02
- Est. completion
- 2030-06-30
- Design
- Double-blind, non-randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join if
- A negative reaction to study drug in ADX-324-301
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (48)
48 openADARx Clinical Site
Litchfield Park, Arizona, United States
Not yet recruitingADARx Clinical Site
Little Rock, Arkansas, United States
Not yet recruitingADARx Clinical Site
San Diego, California, United States
Not yet recruitingADARx Clinical Site
Walnut Creek, California, United States
Not yet recruitingADARx Clinical Site
Orlando, Florida, United States
Not yet recruitingADARx Clinical Site
Chevy Chase, Maryland, United States
Not yet recruitingADARx Clinical Site
Wheaton, Maryland, United States
Not yet recruitingADARx Clinical Site
Detroit, Michigan, United States
Not yet recruitingADARx Clinical Site
St Louis, Missouri, United States
Not yet recruitingADARx Clinical Site
Las Vegas, Nevada, United States
RecruitingADARx Clinical Site
New York, New York, United States
RecruitingADARx Clinical Site
Cincinnati, Ohio, United States
Not yet recruitingADARx Clinical Site
Columbus, Ohio, United States
Not yet recruitingADARx Clinical Site
Toledo, Ohio, United States
Not yet recruitingADARx Clinical Site
Hershey, Pennsylvania, United States
Not yet recruiting
33 sites outside the US
ADARx Clinical Site
Capital Federal, Buenos Aires, Argentina
Not yet recruitingADARx Clinical Site
Buenos Aires, Buenos Aires F.D., Argentina
Not yet recruitingADARx Clinical Site
Adelaide, South Australia, Australia
Not yet recruitingADARx Clinical Site
Vienna, Austria
Not yet recruitingADARx Clinical Site
Edegem, Antwerpen, Belgium
Not yet recruitingADARx Clinical Site
Sofia, Bulgaria
Not yet recruitingADARx Clinical Site
Edmonton, Alberta, Canada
Not yet recruitingADARx Clinical Site
Ottawa, Ontario, Canada
Not yet recruitingADARx Clinical Site
Montreal, Quebec, Canada
Not yet recruitingADARx Clinical Site
Beijing, China
Not yet recruitingADARx Clinical Site
Harbin, China
Not yet recruitingADARx Clinical Site
Zhengzhou, China
Not yet recruitingADARx Clinical Site
Split, Croatia
Not yet recruitingADARx Clinical Site
Zagreb, Croatia
Not yet recruitingADARx Clinical Site
Hradec Králové, Czechia
RecruitingADARx Clinical Site
Prague, Czechia
Not yet recruitingADARx Clinical Site
Nice, Alpes-Maritimes, France
Not yet recruitingADARx Clinical Site
Tours, Indre-et-Loire, France
Not yet recruitingADARx Clinical Site
Montpellier, France
Not yet recruitingADARx Clinical Site
Paris, France
Not yet recruitingADARx Clinical Site
Tübingen, Baden-Wurttemberg, Germany
Not yet recruitingADARx Clinical Site
Hong Kong, Hong Kong
Not yet recruitingADARx Clinical Site
Budapest, Hungary
Not yet recruitingADARx Clinical Site
Ashkelon, Israel
Not yet recruitingADARx Clinical Site
Tel Aviv, Israel
Not yet recruitingADARx Clinical Site
Lodz, Poland
Not yet recruitingADARx Clinical Site
Barcelona, Spain
Not yet recruitingADARx Clinical Site
Madrid, Spain
Not yet recruitingADARx Clinical Site
Taichung, Taiwan
Not yet recruitingADARx Clinical Site
Cambridge, United Kingdom
Not yet recruitingADARx Clinical Site
Cardiff, United Kingdom
Not yet recruitingADARx Clinical Site
London, United Kingdom
Not yet recruitingADARx Clinical Site
Southampton, United Kingdom
Not yet recruiting
Study team
Sponsor
ADARx Pharmaceuticals, Inc.
Study ID ADX-324-302
Study director
Lauge Farnaes, MD
ADARx Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.