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Phase 3Recruiting
View on ClinicalTrials.gov

Comparing ADX-324 Dose Level 1 with ADX-324 Dose Level 2 for hereditary angioedema (HAE)

Official title: 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

Condition: Hereditary Angioedema (HAE)Sponsor: ADARx Pharmaceuticals, Inc.Target enrollment: 90
  • Phase 3
  • 2 groups
  • Sites in Edmonton, Ottawa and 1 more city
  • Recruiting
ADARx Clinical Site, Edmonton, AlbertaADARx Clinical Site, Ottawa, OntarioADARx Clinical Site, Montreal, Quebec

Interventions

  • Medication

    ADX-324 Dose Level 1

    siRNA duplex oligonucleotide

  • Medication

    ADX-324 Dose Level 2

    siRNA duplex oligonucleotide

Canadian Sites (3)

3 listed, none recruiting

  • ADARx Clinical Site

    Edmonton, Alberta

    Not yet recruiting

  • ADARx Clinical Site

    Ottawa, Ontario

    Not yet recruiting

  • ADARx Clinical Site

    Montreal, Quebec

    Not yet recruiting

Eligibility Criteria

See who this study is looking for4 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Completed Study ADX-324-301
  • +Have a documented diagnosis of HAE (Type I or II)
  • +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

  • −A negative reaction to study drug in ADX-324-301
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives ADX-324 Dose Level 1.

Registry label: A: ADX-324 Dose Level 1

Group B receives ADX-324 Dose Level 2.

Registry label: B: ADX-324 Dose Level 2

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

Neither you nor the study team would know which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 90 people.

The study is currently expected to finish around June 2030.

The main measurement is taken over: Month 36.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Safety of ADX-324 in Participants with HAE — measured over Month 36.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07428499 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About ADX-324 Dose Level 1Drug

siRNA duplex oligonucleotide

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About ADX-324 Dose Level 2Drug

siRNA duplex oligonucleotide

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

See how your details line up — get matched
From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

Save this trial to share with your doctor
From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

Neither you nor the study team would know which group you are in until the study ends.

Groups are assigned by the study team using set rules, rather than by chance.

Save this trial to share with your doctor
From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

See how your details line up — get matched
From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Month 36.

The study as a whole is currently expected to finish around 2030-06-30.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

Ask the study team directly
From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 90 people.

Save this trial to share with your doctor
From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 5 locations, including: Edmonton, Alberta, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada; Detroit, Michigan, United States; New York, New York, United States.

Sites can open and close during a study, so confirm with the team before travelling.

Ask the study team directly
From the trial registry
  • trial_locations

About This Trial

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.

Other Sites (2)

ADARx Clinical Site

Detroit, Michigan, United States

ADARx Clinical Site

New York, New York, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.

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