In short
Clinical trials are investigating ADX-324 in people with hereditary angioedema (HAE). These studies aim to see whether ADX-324 can help prevent HAE attacks and measure how well it works compared with placebo, along with other trial outcomes in the studied population.
Key points
- Clinical trials are studying ADX-324 in people with hereditary angioedema, a condition that causes repeated swelling attacks. The main study is a Phase 3 interventional trial called STOP-HAE. It compares ADX-324 with placebo to see whether it can prevent HAE attacks. The trial plans to enroll 89 participants. The main result being measured is the number of investigator-confirmed HAE attacks over time, from Study Day 22 to the Week 25 visit.
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. The study is titled STOP-HAE and is designed to evaluate whether ADX-324 can help prevent HAE attacks.
Study design and treatment groups
This is an interventional trial, which means the research team gives study treatment and compares outcomes between groups. 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).
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.
Who can participate
The trial data show that the target population is people with hereditary angioedema. 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.
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. 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.
This outcome helps show whether ADX-324 can reduce the number of HAE attacks during the study period.
Trial status and size
The trial status is listed as Authorised, which means it has been approved to proceed in the source data. The planned enrollment is 89 participants, so the study is designed to include 89 people in total.