This study involves Hereditary Angioedema, which is a rare inherited condition that causes episodes of swelling in different parts of the body, including 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 or abdomen. The treatment being tested is called Navenibart, also known by its code name STAR-0215. This medication is designed to work against a specific protein in the blood called plasma kallikrein, which plays a role in causing the swelling attacks. Some participants will receive Navenibart while others will receive placebo. The medication is given as an injection under the skin.
The purpose of this study is to assess the long-term safety and tolerability of Navenibart in people with Hereditary Angioedema. The study will also look at how well the medication works in preventing swelling attacks over an extended period of time. Participants in this study will be people who previously took part in another study called STAR-0215-301 and either completed that study or received at least two doses of the medication and were followed for at least two months after the second dose.
During the study, participants will receive regular doses of the medication, with a maximum daily dose of 600 milligrams and a total maximum dose of 9600 milligrams over a treatment period of up to 48 weeks. The study will track any side effects or health problems that occur during treatment. Researchers will also count how many swelling attacks participants experience, including how many are moderate or severe, and how many require emergency treatment. The study will measure whether participants have fewer attacks compared to before treatment, including whether they achieve reductions of 50 percent, 70 percent, or 90 percent in their attack rate, or whether they have no attacks at all. Quality of life will be measured using a questionnaire specifically designed for people with swelling conditions.
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