This clinical trial is focused on studying the effects of a medication called Enpatoran in individuals with certain types of lupus. Lupus is a disease where the immune system attacks healthy tissues, and it can affect the skin, known as cutaneous lupus erythematosus (CLE), or the entire body, known as systemic lupus erythematosus (SLE). The study includes people who have subacute cutaneous lupus erythematosus, discoid lupus erythematosus, and/or systemic lupus erythematosus. The purpose of the study is to evaluate the long-term safety and tolerability of Enpatoran in these participants.
Participants in the study will receive either the medication Enpatoran or a placebo, which looks like the medication but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will be conducted over a long period, allowing researchers to gather information on how well the medication is tolerated and any side effects that may occur.
Throughout the study, participants will be monitored for any adverse events, which are unexpected medical problems that occur during treatment. The study will also look at any changes in laboratory tests and heart function, specifically the QT interval, which is a measure of the heart’s electrical activity. This information will help determine the safety profile of Enpatoran for people with lupus. Participants who successfully complete the initial part of the study may have the opportunity to continue in a long-term extension of the study to gather more data on the medication’s effects.



Bulgaria
Greece
Poland
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