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STOP-HAE: A Phase 3 Study of ADX-324 in HAE
NCT06960213 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ADX-324
Study Locations (14)
Ohio
- ADARx Clinical Site — Cincinnati
- ADARx Clinical Site — Columbus
- ADARx Clinical Site — Toledo
Other
- ADARx Clinical Site — Hradec Králové
- ADARx Clinical Site — Budapest
- ADARx Clinical Site — Madrid
Arkansas
- ADARx Clinical Site — Little Rock
California
- ADARx Clinical Site — Walnut Creek
Maryland
- ADARx Clinical Site — Wheaton
Michigan
- ADARx Clinical Site — Detroit
Missouri
- ADARx Clinical Site — St Louis
Nevada
- ADARx Clinical Site — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-08-28 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06960213
The ClinicalTrials.gov registry entry for NCT06960213 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ADARx Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Hereditary Angioedema appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06960213 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Ohio, Other, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06960213 about?
NCT06960213 is a clinical study titled "STOP-HAE: A Phase 3 Study of ADX-324 in HAE". 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.
What is the current status of trial NCT06960213?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2025-08-28. Estimated completion is 2027-12-31.
What conditions does trial NCT06960213 study?
This clinical trial studies the following conditions: Hereditary Angioedema, HAE, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06960213?
The interventions under investigation include: Placebo (DRUG), ADX-324 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06960213?
This trial is sponsored by ADARx Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06960213 being conducted?
This trial has 14 study locations across Arkansas, California, Maryland, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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