Trials / Recruiting
RecruitingNCT06960213
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- ADARx Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADX-324 | siRNA duplex oligonucleotide |
| DRUG | Placebo | saline |
Timeline
- Start date
- 2025-08-28
- Primary completion
- 2027-06-30
- Completion
- 2027-12-31
- First posted
- 2025-05-07
- Last updated
- 2026-03-02
Locations
14 sites across 5 countries: United States, Canada, Czechia, Hungary, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06960213. Inclusion in this directory is not an endorsement.