Table of contents
- Trial overview
- Study design and treatment groups
- Who can participate
- What the study measures
- Trial status and size
Trial overview
The available trial data describe one study of ADX-324 in hereditary angioedema (HAE), which is a condition that can cause repeated swelling attacks.[1] The study is titled STOP-HAE and is designed to evaluate whether ADX-324 can help prevent HAE attacks.[1]
Study design and treatment groups
This is an interventional trial, which means the research team gives study treatment and compares outcomes between groups.[1] The study includes ADX-324 given as a subcutaneous injection, meaning an injection under the skin, and a placebo comparator listed as sterile normal saline (0.9% sodium chloride solution).[1]
The trial is in Phase 3, which is a later stage of clinical testing that usually focuses on how well a treatment works in a larger group of people.[1]
Who can participate
The trial data show that the target population is people with hereditary angioedema.[1] No extra details are provided in the source about age limits, disease severity, or other entry rules, so the available information only confirms the condition being studied.[1]
What the study measures
The main primary outcome is the time-normalized number of Investigator-confirmed HAE attacks per month from Study Day 22 to the Week 25 Visit for ADX-324 versus placebo.[1] In simple terms, the study is counting how often attacks happen over a set time and comparing the results between the treatment group and the placebo group.[1]
This outcome helps show whether ADX-324 can reduce the number of HAE attacks during the study period.[1]
Trial status and size
The trial status is listed as Authorised, which means it has been approved to proceed in the source data.[1] The planned enrollment is 89 participants, so the study is designed to include 89 people in total.[1]
