A Multi-Center Phase 2/3 Randomized Double-Blind Placebo-Controlled Parallel- Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare

Brief description of study

The main purpose of this study is to see how well an investigational drug called Dapansutrile reduces joint pain and other joint symptoms (such as tenderness and swelling) because of an acute gout flare compared with placebo.

A placebo is an inactive material that looks like Dapansutrile but does not have any Dapansutrile in it. Researchers use a placebo to see if Dapansutrile works better than taking nothing and is safe to use. From here on, Dapansutrile and placebo will be referred to as the “study drug.” An investigational drug is one that has not been approved by regulatory agencies, such as the US Food and Drug Administration (FDA), EU European Medicines Agency (EMA), or others.

Dapansutrile works by stopping certain proteins involved in triggering inflammation. By reducing inflammation, Dapansutrile also has the potential to reduce pain levels due to inflammation in the joints.

Another purpose of this study is to learn more about the safety and tolerability of Dapansutrile, in addition to changes in the levels of the study drug and other molecules circulating in the blood. The study will also help researchers understand how the study drug affects the body and what happens to the study drug as it is processed by the body.

Clinical Study Identifier: s22-01597
Principal Investigator: Michael H Pillinger.

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