Recruiting
Phase 3

ADX-324

Sponsor:

ADARx Pharmaceuticals, Inc.

Code:

NCT07428499

Conditions

Hereditary Angioedema (HAE)

Hereditary Angioedema - Type 1

Hereditary Angioedema - Type 2

HAE

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADX-324 Dose Level 1

ADX-324 Dose Level 2

Study Details

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.

Conditions

Hereditary Angioedema (HAE)

Hereditary Angioedema - Type 1

Hereditary Angioedema - Type 2

HAE

Study ID

NCT07428499

Start date

Apr 2, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADX-324 Dose Level 1

experimental: ADX-324 Dose Level 2

Interventions

ADX-324 Dose Level 1

siRNA duplex oligonucleotide

ADX-324 Dose Level 2

siRNA duplex oligonucleotide

Primary outcome measure

  • Safety of ADX-324 in Participants with HAE [ Time Frame: Month 36 ]

Central Contacts and Locations

Central contacts

Lupe Gallegos

877-232-7974info@adarx.com

Locations

ADARx Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89128

ADARx Clinical Site

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

ADARx Pharmaceuticals, Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Hereditary angioedema
  • HAE
  • ADX-324
  • onvuzosiran

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ADARx Pharmaceuticals, Inc. on 2026-09-04.