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Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

NCT07428499

RecruitingPhase 3

Sponsor: ADARx Pharmaceuticals, Inc.

Conditions: Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, HAE

Interventions: ADX-324 Dose Level 1, ADX-324 Dose Level 2

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* A negative reaction to study drug in ADX-324-301
Locations (48)
  • Litchfield Park, Arizona, United States
  • Little Rock, Arkansas, United States
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Orlando, Florida, United States
  • Chevy Chase, Maryland, United States
  • Wheaton, Maryland, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Toledo, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Capital Federal, Buenos Aires, Argentina
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Adelaide, South Australia, Australia
  • Vienna, Austria
  • Edegem, Antwerpen, Belgium
  • Sofia, Bulgaria
  • Edmonton, Alberta, Canada
  • Ottawa, Ontario, Canada
  • Montreal, Quebec, Canada
  • Beijing, China
  • Harbin, China
  • Zhengzhou, China
  • Split, Croatia
  • Zagreb, Croatia
  • Hradec Králové, Czechia
  • + 18 more on CT.gov