Actively Recruiting
Phase 3 Trial of ADX-324 Treatment for Adults with Type 1 or Type 2 Hereditary Angioedema
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-06-16
90
Participants Needed
51
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ADX-324 in adults diagnosed with Type 1 or Type 2 hereditary angioedema HAE. This Phase 3 study also assesses pharmacokinetics, pharmacodynamics, and the impact on health-related quality of life measures for participants with this condition. The trial is sponsored by ADARx Pharmaceuticals, Inc. and aims to prevent HAE attacks while understanding the drugs overall effects. Participants are randomly assigned to one of three groups two different dose levels of ADX-324, which is an siRNA duplex oligonucleotide drug, or a placebo containing saline. The study uses a quadruple-blind design to evaluate the treatments over a period from Day 22 to Week 25. The trial includes screening to confirm eligibility and monitors participants closely while receiving the study drug or placebo. During the study, participants undergo regular assessments to measure the frequency and quality of HAE attacks, safety evaluations, and collect data on drug behavior in the body. Researchers also observe pharmacodynamics and health quality of life changes. The primary outcome focuses on preventing HAE attacks within the main treatment period, with secondary outcomes exploring attack characteristics. The total study duration extends through the treatment and monitoring phases until study completion in late 2027.
CONDITIONS
Brief Title
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
Research Team
L
Lupe Gallegos
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