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NCT Number: NCT07428499

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

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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn HAE Hereditary Angioedema - Type 1 Hereditary Angioedema - Type 2 Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ADARx Clinical Site, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX-324 Dose Level 1

Drug

siRNA duplex oligonucleotide

ADX-324 Dose Level 2

Drug

siRNA duplex oligonucleotide

Primary outcomes

  1. Safety of ADX-324 in Participants with HAE

    Time frame: Month 36

    Incidence and severity of treatment-emergent adverse events

Secondary outcomes

  1. Efficacy of ADX-324 in Preventing HAE Attacks

    Time frame: Month 36

    Number of Investigator-confirmed HAE attacks per month

Study contacts

Contact information is provided by the study sponsor or research team.

Lupe Gallegos

CONTACT

[email protected]

877-232-7974

Sponsors and collaborators

Lead sponsor

ADARx Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 23, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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