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RECRUITING
NCT06960213
PHASE3

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

Sponsor: ADARx Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.

Official title: STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-08-28

Completion Date

2027-12-31

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

DRUG

ADX-324

siRNA duplex oligonucleotide

DRUG

Placebo

saline

Locations (51)

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

Ramat Gan, Tel Aviv, Israel

ADARx Clinical Site

Ashkelon, Israel

ADARx Clinical Site

Tel Aviv, Israel

ADARx Clinical Site

Krakow, Poland

ADARx Clinical Site

Lodz, Poland

ADARx Clinical Site

Wroclaw, 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