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

June 12, 2026 updated by: ADARx Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lupe Gallegos
  • Phone Number: 877-232-7974
  • Email: info@adarx.com

Study Locations

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1425BEN
        • Not yet recruiting
        • ADARx Clinical Site
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1035AAT
        • Not yet recruiting
        • ADARx Clinical Site
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Not yet recruiting
        • ADARx Clinical Site
  • Austria
      • Vienna, Austria, 1090
        • Not yet recruiting
        • ADARx Clinical Site
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Not yet recruiting
        • ADARx Clinical Site
  • Bulgaria
      • Sofia, Bulgaria, 1000
        • Not yet recruiting
        • ADARx Clinical Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • Not yet recruiting
        • ADARx Clinical Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1E4
        • Not yet recruiting
        • ADARx Clinical Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Not yet recruiting
        • ADARx Clinical Site
  • China
      • Beijing, China, 100730
        • Not yet recruiting
        • ADARx Clinical Site
      • Harbin, China, 150001
        • Not yet recruiting
        • ADARx Clinical Site
      • Zhengzhou, China, 450003
        • Not yet recruiting
        • ADARx Clinical Site
  • Croatia
      • Split, Croatia, 21000
        • Not yet recruiting
        • ADARx Clinical Site
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • ADARx Clinical Site
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Not yet recruiting
        • ADARx Clinical Site
      • Prague, Czechia, 15000
        • Not yet recruiting
        • ADARx Clinical Site
  • France
      • Montpellier, France, 34295
        • Not yet recruiting
        • ADARx Clinical Site
      • Paris, France, 75012
        • Not yet recruiting
        • ADARx Clinical Site
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06300
        • Not yet recruiting
        • ADARx Clinical Site
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Not yet recruiting
        • ADARx Clinical Site
  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Not yet recruiting
        • ADARx Clinical Site
  • Hong Kong
      • Hong Kong, Hong Kong, 111
        • Not yet recruiting
        • ADARx Clinical Site
  • Hungary
      • Budapest, Hungary, 1088
        • Not yet recruiting
        • ADARx Clinical Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Not yet recruiting
        • ADARx Clinical Site
      • Tel Aviv, Israel, 5262100
        • Not yet recruiting
        • ADARx Clinical Site
  • Poland
      • Lodz, Poland, 92-213
        • Not yet recruiting
        • ADARx Clinical Site
  • Spain
      • Barcelona, Spain, 08907
        • Not yet recruiting
        • ADARx Clinical Site
      • Madrid, Spain, 28007
        • Not yet recruiting
        • ADARx Clinical Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • ADARx Clinical Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Not yet recruiting
        • ADARx Clinical Site
      • Cardiff, United Kingdom, CF14 4YS
        • Not yet recruiting
        • ADARx Clinical Site
      • London, United Kingdom, E1 1BB
        • Not yet recruiting
        • ADARx Clinical Site
      • Southampton, United Kingdom, SO16 6YD
        • Not yet recruiting
        • ADARx Clinical Site
  • United States
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Not yet recruiting
        • ADARx Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • ADARx Clinical Site
    • California
      • San Diego, California, United States, 92122
        • Not yet recruiting
        • ADARx Clinical Site
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • ADARx Clinical Site
    • Florida
      • Orlando, Florida, United States, 32807
        • Not yet recruiting
        • ADARx Clinical Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Not yet recruiting
        • ADARx Clinical Site
      • Wheaton, Maryland, United States, 20902
        • Not yet recruiting
        • ADARx Clinical Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • ADARx Clinical Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Not yet recruiting
        • ADARx Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • ADARx Clinical Site
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • ADARx Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Not yet recruiting
        • ADARx Clinical Site
      • Columbus, Ohio, United States, 43235
        • Not yet recruiting
        • ADARx Clinical Site
      • Toledo, Ohio, United States, 43617
        • Not yet recruiting
        • ADARx Clinical Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Not yet recruiting
        • ADARx Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADX-324 Dose Level 1
Drug: ADX-324 Dose Level 1
siRNA duplex oligonucleotide
Experimental: ADX-324 Dose Level 2
Drug: ADX-324 Dose Level 2
siRNA duplex oligonucleotide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADARx Pharmaceuticals, Inc.

Investigators

  • Study Director: Lauge Farnaes, MD, ADARx Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-324-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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