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

April 27, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ADARx Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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