This study is looking at a condition called Hereditary Angioedema, which is a rare genetic disorder that causes repeated episodes of severe swelling in different parts of the body such as the hands, feet, face, intestinal tract, and airways. These swelling episodes, called attacks, can be painful and potentially dangerous, especially when they affect the throat and airways. The study will test a medication called ADX-324, which is given as an injection under the skin, against placebo to see if it can help prevent these swelling attacks from happening. The purpose of the study is to find out if ADX-324 works to prevent swelling attacks in people with this condition.
The study is designed so that participants will be randomly assigned to receive either ADX-324 or placebo. The study is double-blind, which means that neither the participants nor the doctors will know who is receiving the actual medication or placebo during the treatment period. Before starting the treatment, there will be a screening period lasting up to eight weeks to confirm that participants have the right type of condition and experience swelling attacks frequently enough to be part of the study. During this screening time, doctors will check medical history and confirm the diagnosis through specific blood tests that measure certain proteins and complement levels in the blood.
The treatment period will last for 25 weeks, during which participants will receive regular injections of either ADX-324 or sterile normal saline, which is the placebo. Throughout the study, participants will need to keep track of any swelling attacks they experience and will have access to rescue medication that they have used before to treat attacks when they occur. The study will measure how many swelling attacks occur during the treatment period, how many attacks require the use of rescue medication, and how many participants remain free from attacks. Doctors will also look at the severity of any attacks that do occur and compare the results between those receiving ADX-324 and those receiving placebo.



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