NCT07428499

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: ADARx Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ADX-324 Dose Level 1	siRNA duplex oligonucleotide
DRUG	ADX-324 Dose Level 2	siRNA duplex oligonucleotide

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2026-02-23
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study