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STOP-HAE: A Phase 3 Study of ADX-324 in HAE

NCT06960213 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-18

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.

Conditions

Interventions

DRUG

ADX-324

siRNA duplex oligonucleotide

DRUG

Placebo

saline

Sponsors & Collaborators

  • ADARx Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Lauge Farnaes, MD · ADARx Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2027-06-30
Completion
2027-12-31
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

Drugs
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 NCT06960213 on ClinicalTrials.gov