The KOMPLETE Study

A clinical research study for adults with Hereditary Angioedema (HAE) type I or type II

Purpose of the KOMPLETE Study

The purpose of the KOMPLETE Study is to understand the effects of an investigational oral medication called KVD824 in adults 18 years of age and older with HAE type I or type II. Investigational means that KVD824 has not yet been approved to treat HAE and can only be used in a research study. Doctors are studying 3 different doses to see which one may be best as a safe prophylaxis treatment for HAE attacks (meaning whether or not it works to prevent attacks).

About KVD824

KVD824 is an investigational oral medication designed to prevent HAE attacks. It works by inhibiting the activation of plasma kallikrein, which reduces swelling and may help in the treatment of HAE. KVD824 is a tablet that is taken by mouth.

Who can participate in this study

The KOMPLETE Study is for adults 18 years of age and older. You may be able to participate if:
You have a confirmed diagnosis of HAE type I or type II
You have access to and are able to use on-demand medication for HAE attacks
You are willing to attend all study visits
You are willing to provide information about your HAE attacks in an electronic diary
You are willing to use a study approved method for birth control during the study

What to expect during the study

The KOMPLETE Study will last approximately 32 weeks with up to 7 visits for health checks and tests at no cost to you.
If you join the study, you will be placed by chance in a treatment group to receive 1 of 3 doses of KVD824 or placebo. The placebo looks like KVD824 but does not have medicine in it. This helps the researchers to better understand the effects of KVD824.

Electronic diary

You will use an electronic diary to answer questions about your HAE attacks and to keep track of your study medication dosing. The diary will be provided to you to use during the study.

Taking the study medication

The study medication comes as tablets to be taken by mouth. You will take the number of tablets as instructed two times a day (about every 12 hours with morning and evening meals).
If the study medication does not prevent an attack, you may treat it with an approved HAE treatment agreed upon with your study doctor.
You will be monitored continuously throughout the study for any changes in health or potential side effects.
To learn more about the KOMPLETE Study, and to find a study site near you, call (877) 223-3576, and use code: 25885.

Find a KOMPLETE study site near you

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