RecruitingPhase 3NCT07428499

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


Sponsor

ADARx Pharmaceuticals, Inc.

Enrollment

90 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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)

Exclusion Criteria1

  • A negative reaction to study drug in ADX-324-301

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Interventions

DRUGADX-324 Dose Level 1

siRNA duplex oligonucleotide

DRUGADX-324 Dose Level 2

siRNA duplex oligonucleotide


Locations(48)

ADARx Clinical Site

Litchfield Park, Arizona, United States

ADARx Clinical Site

Little Rock, Arkansas, United States

ADARx Clinical Site

San Diego, California, United States

ADARx Clinical Site

Walnut Creek, California, United States

ADARx Clinical Site

Orlando, Florida, United States

ADARx Clinical Site

Chevy Chase, Maryland, United States

ADARx Clinical Site

Wheaton, Maryland, United States

ADARx Clinical Site

Detroit, Michigan, United States

ADARx Clinical Site

St Louis, Missouri, United States

ADARx Clinical Site

Las Vegas, Nevada, United States

ADARx Clinical Site

New York, New York, United States

ADARx Clinical Site

Cincinnati, Ohio, United States

ADARx Clinical Site

Columbus, Ohio, United States

ADARx Clinical Site

Toledo, Ohio, United States

ADARx Clinical Site

Hershey, Pennsylvania, United States

ADARx Clinical Site

Capital Federal, Buenos Aires, Argentina

ADARx Clinical Site

Buenos Aires, Buenos Aires F.D., Argentina

ADARx Clinical Site

Adelaide, South Australia, Australia

ADARx Clinical Site

Vienna, Austria

ADARx Clinical Site

Edegem, Antwerpen, Belgium

ADARx Clinical Site

Sofia, Bulgaria

ADARx Clinical Site

Edmonton, Alberta, Canada

ADARx Clinical Site

Ottawa, Ontario, Canada

ADARx Clinical Site

Montreal, Quebec, Canada

ADARx Clinical Site

Beijing, China

ADARx Clinical Site

Harbin, China

ADARx Clinical Site

Zhengzhou, China

ADARx Clinical Site

Split, Croatia

ADARx Clinical Site

Zagreb, Croatia

ADARx Clinical Site

Hradec Králové, Czechia

ADARx Clinical Site

Prague, Czechia

ADARx Clinical Site

Nice, Alpes-Maritimes, France

ADARx Clinical Site

Tours, Indre-et-Loire, France

ADARx Clinical Site

Montpellier, France

ADARx Clinical Site

Paris, France

ADARx Clinical Site

Tübingen, Baden-Wurttemberg, Germany

ADARx Clinical Site

Hong Kong, Hong Kong

ADARx Clinical Site

Budapest, Hungary

ADARx Clinical Site

Ashkelon, Israel

ADARx Clinical Site

Tel Aviv, Israel

ADARx Clinical Site

Lodz, Poland

ADARx Clinical Site

Barcelona, Spain

ADARx Clinical Site

Madrid, Spain

ADARx Clinical Site

Taichung, Taiwan

ADARx Clinical Site

Cambridge, United Kingdom

ADARx Clinical Site

Cardiff, United Kingdom

ADARx Clinical Site

London, United Kingdom

ADARx Clinical Site

Southampton, United Kingdom

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NCT07428499


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