Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADX-324 Dose Level 1, ADX-324 Dose Level 2.
- Who it may be relevant to
- Registry conditions: Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, HAE. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +14
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
Overview
Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.
Interventions
- Drug ADX-324 Dose Level 1
siRNA duplex oligonucleotide - Drug ADX-324 Dose Level 2
siRNA duplex oligonucleotide
Primary outcome measures
- Safety of ADX-324 in Participants with HAE [Time frame: Month 36]
Secondary outcome measures (1)
- Efficacy of ADX-324 in Preventing HAE Attacks [Time frame: Month 36]
Eligibility criteria
Inclusion criteria
- Have a documented diagnosis of HAE (Type I or II)
- Completed Study ADX-324-301
- Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)
Exclusion criteria
- A negative reaction to study drug in ADX-324-301
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- ADARx Clinical Site — Litchfield Park
- ADARx Clinical Site — Little Rock
- ADARx Clinical Site — San Diego
- ADARx Clinical Site — Walnut Creek
- ADARx Clinical Site — Orlando
- ADARx Clinical Site — Chevy Chase
- ADARx Clinical Site — Wheaton
- ADARx Clinical Site — Detroit
- … and 7 more centers
France · 4 centers
- ADARx Clinical Site — Nice
- ADARx Clinical Site — Tours
- ADARx Clinical Site — Montpellier
- ADARx Clinical Site — Paris
United Kingdom · 4 centers
- ADARx Clinical Site — Cambridge
- ADARx Clinical Site — Cardiff
- ADARx Clinical Site — London
- ADARx Clinical Site — Southampton
Canada · 3 centers
- ADARx Clinical Site — Edmonton
- ADARx Clinical Site — Ottawa
- ADARx Clinical Site — Montreal
China · 3 centers
- ADARx Clinical Site — Beijing
- ADARx Clinical Site — Harbin
- ADARx Clinical Site — Zhengzhou
Argentina · 2 centers
- ADARx Clinical Site — Capital Federal
- ADARx Clinical Site — Buenos Aires
Croatia · 2 centers
- ADARx Clinical Site — Split
- ADARx Clinical Site — Zagreb
Czechia · 2 centers
- ADARx Clinical Site — Hradec Králové
- ADARx Clinical Site — Prague
Israel · 2 centers
- ADARx Clinical Site — Ashkelon
- ADARx Clinical Site — Tel Aviv
Spain · 2 centers
- ADARx Clinical Site — Barcelona
- ADARx Clinical Site — Madrid
Australia · 1 center
- ADARx Clinical Site — Adelaide
Austria · 1 center
- ADARx Clinical Site — Vienna
Belgium · 1 center
- ADARx Clinical Site — Edegem
Bulgaria · 1 center
- ADARx Clinical Site — Sofia
Germany · 1 center
- ADARx Clinical Site — Tübingen
Hong Kong · 1 center
- ADARx Clinical Site — Hong Kong
Hungary · 1 center
- ADARx Clinical Site — Budapest
Poland · 1 center
- ADARx Clinical Site — Lodz
Taiwan · 1 center
- ADARx Clinical Site — Taichung
Identifiers
NCT: NCT07428499 · ADX-324-302