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

NCT07428499 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-30

No results posted yet for this study

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

Interventions

DRUG

ADX-324 Dose Level 1

siRNA duplex oligonucleotide

DRUG

ADX-324 Dose Level 2

siRNA duplex oligonucleotide

Sponsors & Collaborators

  • ADARx Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Lauge Farnaes, MD · ADARx Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2030-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428499 on ClinicalTrials.gov