1. Trial Details/Purpose

Around 50% of people with gout experience at least one flare annually, and 10-20% have frequent flares. These flares typically last 3-14 days if untreated. 75% of gout sufferers report flares affect their quality of life. Frequent flares (more than 3 per year) can cause joint damage and tophi. 40% of individuals have inadequately treated flares.  The clinical trial NCT05658575 is a multi-center study evaluating the safety and effectiveness of Dapansutrile tablets in treating acute gout flares. This trial is in Phase 2/3, which means it's looking at both the effectiveness and side effects of the medication on a larger group of participants. Participants in the trial are randomly assigned to receive either the Dapansutrile or a placebo. Those in the Dapansutrile group take an initial loading dose followed by a maintenance dose for a week, mirroring the placebo group's regimen.  The study specifically targets adults diagnosed with gout, and participants are required to meet specific criteria, such as having a recent gout flare and not having certain other medical conditions. The trial is ongoing across various locations and is not accepting healthy volunteers. The objective is to see if Dapansutrile can effectively reduce the pain and symptoms of a gout flare compared to a placebo.​

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​2. Inclusion Criteria

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• Male and female subjects aged 18 or older.

• Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria, which can be confirmed by the presence of monosodium urate crystals in the target joint or bursa, imaging evidence of urate deposition, or a documented history of gout flares.

• A gout flare in the target joint that began within 96 hours prior to the baseline visit.

• Ability to provide written informed consent and comply with all trial requirements

 

3. Exclusion Criteria

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• Visible tophi or more than four joints with an acute gout flare at baseline.

• Active rheumatoid arthritis or other acute inflammatory arthritis, or suspicion of infectious/septic arthritis.

• Significant non-gout-related joint pain or general pain that could interfere with pain assessment of the target joint.

• Known chronic kidney disease or renal impairment.

• Positive test for SARS-CoV-2 infection within 4 weeks of the baseline visit.

• Active malignancy or recent cancer treatment.

• Known allergy or hypersensitivity to Dapansutrile or similar drugs, as well as to paracetamol/acetaminophen.

• Use of prohibited medications close to the baseline visit or planned during the trial

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location​

 

     Tarzana​​​​​​