STOP-HAE: ADX-324 for hereditary angioedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, placebo-controlled trial compares ADX-324 to placebo in adults with HAE type 1 or 2 who have had recent investigator-confirmed attacks. Participants must meet entry criteria including attack frequency during screening and the ability to use at least one approved acute therapy. The trial will collect efficacy outcomes, safety data, pharmacokinetics/pharmacodynamics, and health-related quality of life measures. Dosing and follow-up occur at ADARx clinical sites in the United States.

Why it matters

Who can join: the full rules

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.

Where it's running

• ADARx Clinical Site
  Litchfield Park, Arizona, United States Recruiting
• ADARx Clinical Site
  Scottsdale, Arizona, United States Recruiting
• ADARx Clinical Site
  Little Rock, Arkansas, United States Recruiting
• ADARx Clinical Site
  San Diego, California, United States Recruiting
• ADARx Clinical Site
  Walnut Creek, California, United States Recruiting
• ADARx Clinical Site
  Centennial, Colorado, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Lupe Gallegos
• Email: info@adarx.com
• Phone: 877-232-7974

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term treatment with ADX-324 for people with hereditary angioedema

  This extension will try additional doses of ADX-324 (onvuzosiran) to see if continuing the drug is safe and helps people with Type I or II hereditary angioedema who finished the earlier Phase 3 trial.

  Recruiting at 3 sites Phase 3 ADARx Pharmaceuticals, Inc. · Litchfield Park, Arizona and 47 other locations · NCT07428499

• Daily phone surveys to track the real-life burden of hereditary angioedema

  The study will try daily phone surveys to see if they reveal a higher and more changeable burden of disease than standard questionnaires in adults with hereditary angioedema.

  Recruiting Istituti Clinici Scientifici Maugeri SpA · Milan · NCT07448181

• Sebetralstat before procedures for hereditary angioedema

  This trial tests whether a single 600 mg dose of sebetralstat can safely and effectively prevent angioedema attacks around planned procedures in people aged 12 and older with hereditary angioedema.

  Recruiting Phase 4 KalVista Pharmaceuticals, Ltd. · Colorado Springs, Colorado · NCT07654829

• Hemorrhoidal artery embolization versus rubber band ligation for internal hemorrhoid bleeding

  This trial will test whether hemorrhoidal artery embolization or rubber band ligation better stops bleeding and improves symptoms in adults with internal hemorrhoids.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07559630

• Hemorrhoidal artery embolization to improve internal hemorrhoid symptoms

  This trial will try blocking enlarged hemorrhoidal arteries to reduce bleeding and other symptoms in adults with symptomatic internal hemorrhoids who cannot or will not have surgery.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07179601

• Registry for Rare Diseases

  This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.