Long-term treatment with ADX-324 for people with 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 extension enrolls participants who completed the Phase 3 ADX-324-301 trial to continue receiving ADX-324 at one of two dose levels while researchers monitor safety and effectiveness. The protocol collects pharmacodynamic (PD) and pharmacokinetic (PK) data, tracks health-related quality of life (HRQoL), and records any HAE attacks or use of acute therapies. Participants must have documented Type I or II HAE and access to acute treatment for attacks. Follow-up visits occur at ADARx clinical sites in the United States and focus on longer-term tolerability and clinical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• ADARx Clinical Site
  Las Vegas, Nevada, United States Recruiting
• ADARx Clinical Site
  New York, New York, United States Recruiting
• ADARx Clinical Site
  Hradec Králové, Czechia Recruiting
• ADARx Clinical Site
  Litchfield Park, Arizona, United States Not yet recruiting
• ADARx Clinical Site
  Little Rock, Arkansas, United States Not yet recruiting
• ADARx Clinical Site
  San Diego, California, United States Not yet recruiting

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.

• STOP-HAE: ADX-324 for hereditary angioedema

  This trial tests whether ADX-324 can reduce HAE attacks in adults with Type 1 or Type 2 hereditary angioedema.

  Recruiting at 52 sites Phase 3 ADARx Pharmaceuticals, Inc. · Litchfield Park, Arizona and 69 other locations · NCT06960213

• 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

• 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

• Takhzyro use in teenagers and adults with hereditary angioedema in South Korea

  This study looks at how safe and useful Takhzyro is when used in real-world care for teenagers and adults with hereditary angioedema in South Korea.

  Recruiting at 3 sites Takeda · Suwon, Gyeonggi-do and 2 other locations · NCT07445087

• Donidalorsen for children with hereditary angioedema

  This trial tests if donidalorsen is safe and how it is processed in the body for children aged 2 to under 12 with hereditary angioedema types I or II.

  Recruiting at 18 sites Phase 3 Ionis Pharmaceuticals, Inc. · Santa Monica, California and 17 other locations · NCT07298447

• C1-Inhibitor Function Test to Diagnose HAE in Algeria

  A test that measures C1-inhibitor function is being tried to see if it can accurately diagnose hereditary angioedema in patients in Algeria.

  Recruiting Takeda · Algiers · NCT07293364

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.