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STOP-HAE: ADX-324 for hereditary angioedema

STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

PHASE3 · ADARx Pharmaceuticals, Inc. · NCT06960213

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

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorADARx Pharmaceuticals, Inc. (industry)
Drugs / interventionsLanadelumab
Locations50 sites (Litchfield Park, Arizona and 49 other locations)
Trial IDNCT06960213 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with a documented diagnosis of HAE Type 1 or Type 2 who have had at least one investigator-confirmed attack in the first 4 weeks of screening or two attacks in 8 weeks and can use an acute HAE therapy are ideal candidates.

Not a fit: People with other forms of recurrent angioedema, clinically significant renal or hepatic disease, or recent use of certain long-term HAE prevention medications are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, ADX-324 could lower the number and severity of HAE attacks and improve patients' quality of life.

How similar studies have performed: Earlier-phase testing of ADX-324 and related agents showed signals of activity that supported moving this treatment into a Phase 3 trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Litchfield Park, Arizona and 49 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 →

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

Last reviewed 2026-05-15 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.