Phase 3 Extension Study of ADX-324 in Participants With H... | NCT07428499

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

NCT07428499

Sponsor

ADARx Pharmaceuticals, Inc.

Status

Recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

90Estimated

Phase

Phase 3

Conditions

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

Interventions

ADX-324 Dose Level 1
ADX-324 Dose Level 2

Countries

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

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2026Actual

Primary Completion Date

Jun 30, 2030Estimated

Completion Date

Jun 30, 2030Estimated

First Submitted Date

Feb 19, 2026

First Submission Date that Met QC Criteria

Feb 19, 2026

First Posted Date

Feb 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADX-324 Dose Level 1	Experimental		Drug: ADX-324 Dose Level 1
ADX-324 Dose Level 2	Experimental		Drug: ADX-324 Dose Level 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADX-324 Dose Level 1	Drug	siRNA duplex oligonucleotide	ADX-324 Dose Level 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lupe Gallegos	Contact	877-232-7974		info@adarx.com

Overall Officials

Name	Affiliation	Role
Lauge Farnaes, MD	ADARx Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ADARx Clinical Site	Not yet recruiting	Litchfield Park	Arizona	85340	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Ancestor Terms

ID	Term
D000799	Angioedema
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000081208	Hereditary Complement Deficiency Diseases
D000081207	Primary Immunodeficiency Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D007153	Immunologic Deficiency Syndromes