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NCT06960213 · ClinicalTrials.gov registry record · Phase 3
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
A Phase 3 study of Hereditary Angioedema and HAE, sponsored by ADARx Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 14
- Study locations
NCT06960213: Recruiting Phase 3 study of Hereditary Angioedema and HAE, sponsored by ADARx Pharmaceuticals.
NCT06960213 is a Phase 3 study of Hereditary Angioedema and HAE that is actively recruiting participants, run by ADARx Pharmaceuticals. The registered enrollment target is 90 participants, above the 69-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (30% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06960213, a Phase 3 study of Hereditary Angioedema and HAE, is actively recruiting participants, sponsored by ADARx Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
The time-normalized number of Investigator-confirmed HAE attacks per month for ADX-324 Dose Level 1 vs placebo
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 |
What NCT06960213 shows while recruiting
NCT06960213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 69-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (30% higher).
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.
NCT06960213 lists 14 locations in 10 states (Ohio, Other, Arkansas).
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.
What interventions are being tested in trial NCT06960213?
The interventions under investigation include: Placebo (DRUG), ADX-324 (DRUG).
Who is sponsoring clinical trial NCT06960213?
This trial is sponsored by ADARx Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hereditary Angioedema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06960213's enrollment target sits among peer trials
90 5th of 14 higher than 10 of 14 other Hereditary Angioedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hereditary Angioedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
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A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
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HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
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PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
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Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
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OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
COMPLETED · Phase 3
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