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

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Phase 3 Interventional ADARx Pharmaceuticals, Inc. · NCT07428499

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.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorADARx Pharmaceuticals, Inc. Industry-sponsored
Locations48 sites (Litchfield Park, Arizona and 47 other locations)
Trial IDNCT07428499 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with documented Type I or II hereditary angioedema who completed the ADX-324-301 trial and have access to acute HAE therapy.

Not a fit: Patients who had a negative reaction to ADX-324 in the prior trial or who do not have Type I/II HAE are unlikely to benefit from joining this extension.

Why it matters

Potential benefit: If successful, continuing ADX-324 could reduce HAE attack frequency and provide longer-term safety and quality-of-life information for people with Type I or II HAE.

How similar studies have performed: Earlier ADX-324 trials, including the preceding Phase 3, have provided preliminary efficacy and safety data, and RNAi-based therapies in other diseases have shown feasibility, but long-term extension data for this approach in HAE remain limited.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Litchfield Park, Arizona and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hereditary AngioedemaHereditary Angioedema - Type 1Hereditary Angioedema - Type 2HAEHereditary angioedemaADX-324onvuzosiran
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.