This study looks at a condition called primary immunodeficiency, which is a disorder where the immune system does not work properly and can lead to various health problems including abnormal immune responses in the body. The treatment being studied is leniolisib, which is also known by its code name CDZ173. This medication comes in the form of film coated tablets that are taken by mouth. The study will use different dose strengths of the medication, with maximum daily amounts of 20, 60, or 140 milligrams depending on what is appropriate for each person.
The purpose of this study is to assess the long-term safety and how well the body tolerates leniolisib when used to treat immune problems in people with primary immunodeficiency. This is an extension study, which means it is designed for people who have already participated in earlier studies of this medication and who their doctors believe would benefit from continuing to take leniolisib. The study will monitor for any unwanted effects or side effects through regular check-ups, vital sign measurements, safety laboratory tests, and physical examinations.
During the study, participants will continue taking leniolisib for an extended period, with the treatment lasting up to 156 weeks. The study will track various health measures over time, including blood cell counts such as hemoglobin, platelets, and different types of white blood cells. Doctors will also monitor lung function through breathing tests and imaging scans, check for changes in lymph nodes and spleen size, and measure certain substances in the blood that indicate how the immune system is functioning. All of these measurements help researchers understand how well the medication works over a long period and whether it remains safe for continued use.
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