Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07428499

Enrollment

Registered

2026-02-23

Start date

2026-04-02

Completion date

2030-06-30

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HAE, Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2

Keywords

Hereditary angioedema, HAE, ADX-324, onvuzosiran

Brief summary

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

DRUGADX-324 Dose Level 1

siRNA duplex oligonucleotide

DRUGADX-324 Dose Level 2

siRNA duplex oligonucleotide

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of ADX-324 in Participants with HAE	Month 36	Incidence and severity of treatment-emergent adverse events

Secondary

Measure	Time frame	Description
Efficacy of ADX-324 in Preventing HAE Attacks	Month 36	Number of Investigator-confirmed HAE attacks per month

Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Poland, Spain, Taiwan, United Kingdom, United States

Contacts

CONTACTLupe Gallegos

info@adarx.com877-232-7974

STUDY_DIRECTORLauge Farnaes, MD

ADARx Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026