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Clinical Trial ● Currently Recruiting Phase III NCT06960213

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

STOP-HAE: A Phase 3 Study of ADX-324 in HAE — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06960213.

📅 22 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06960213
Sponsor
ADARx Pharmaceuticals, Inc.
Start
2025-08-28
ClinicaliQ Trial Snapshot
  • STOP-HAE: A Phase 3 Study of ADX-324 in HAE — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06960213.
  • What is being tested: ADX-324, a novel therapeutic agent, is being evaluated in a Phase 3 trial to assess its efficacy and safety in treating Type 1 and Type 2 hereditary angioedema (HAE), alongside pharmacokinetic/pharmacodynamic profiles and quality of life outcomes.
  • Patient eligibility overview: The trial enrolls patients with confirmed Type 1 or Type 2 HAE, representing the two most common genetic variants of this rare condition affecting complement system regulation.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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