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

NCT06960213

RecruitingPhase 3

Sponsor: ADARx Pharmaceuticals, Inc.

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

Interventions: ADX-324, Placebo

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

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Age ≥18 years at the time of signing informed consent.
* Have a documented diagnosis of HAE-1/HAE-2 (Type I or II)
* Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening
* Able to use at least one acute therapy to treat HAE attacks (such as a plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)

Key Exclusion Criteria:

* Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria).
* Any clinically significant renal disease
* Any clinically significant hepatic disease
* Have used any of the following for long-term prevention of HAE attacks:

  1. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
  2. Berotralstat (ORLADEYO) within 3 weeks prior to Screening.
  3. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.
  4. Androgen use within 12 weeks prior to Screening.
* Received prior treatment with any RNA/DNA-based therapy for HAE or intolerant to any prior RNA/DNA-based therapy for any condition, excluding vaccines.
Locations (51)
  • 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
  • + 21 more on CT.gov