Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

To be considered for this study, you need to be at least 18 years old. You must have a clear diagnosis of gout, and importantly, you need to be experiencing an active gout flare-up that started within the last four days.

There are some reasons why you might not be able to join. For example, if you have more than three joints affected by gout at the moment, or if you have any other types of severe arthritis like rheumatoid arthritis. We also can't include you if you have signs of an infection in your joint, or if you have other serious pain that would make it hard to tell if the gout treatment is working.

Also, if you have severe kidney problems, certain serious illnesses, or recent cancer treatment, this study might not be suitable. It's crucial that you don't have an allergy to the study medication or to paracetamol, and that you or your doctor aren't planning to use certain other medications that might interfere with the study treatment.

If you choose to take part, you'll first have a screening visit to make sure the study is right for you. If you qualify, you'll be given either the dapansutrile tablet or a placebo tablet to take twice a day for seven days. The study treatment is provided as an initial larger 'loading dose' on the first day, followed by smaller, regular doses.

During the study, you'll need to return to the clinic for check-ups. You'll have a visit on Day 4 while you're still taking the medication, and then after you've finished the seven days of treatment, you'll have follow-up visits on Day 8 and Day 15. The research team will continue to collect information about your safety up to Day 36. During the main treatment period, you won't be able to take other pain medicines, anti-inflammatory drugs (like steroids or NSAIDs), or most other gout treatments, but you will be given 'rescue medication' if your pain becomes unmanageable.