Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Inclusion Criteria: Male and female subjects age 18 or older Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria: A) For newly presenting subjects: Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by imaging evidence of urate deposition in the target joint or bursa at the Screening/Baseline Visit/Study Day 1, or B) For previously diagnosed subjects: Confirmation of gout diagnosis as per criterion 2a OR history of gout diagnosis per one of the following: a. Documented history of the presence of MSU crystals in synovial fluid from the target joint or bursa ; or b. Historical imaging report of urate deposition in the target joint or bursa in their medical record5; or c. Documented history of 2 or more gout flares in the previous 18 months Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening/Baseline Visit Provide written informed consent and understand and comply with all trial requirements Exclusion Criteria: Presence of any palpable and visible tophi by physical examination Has ≥ 4 joints with an acute gout flare at Screening/Baseline Presence of rheumatoid arthritis or other acute inflammatory arthritis Evidence/suspicion of infectious/septic arthritis Clinically significant general pain or non-gout-related joint pain that would interfere with the subject's ability to accurately assess pain in the target joint Known diagnosis of chronic kidney disease or known history of renal impairment Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening/Baseline Active malignancy or recent malignancy with any systemic anti-cancer treatment Has a hypersensitivity or allergy to OLT1177® or other drugs in its class Hypersensitivity or allergy to paracetamol/acetaminophen Use of any prohibited concomitant medications/therapies over the periods defined in the protocol or planned use of any prohibited concomitant medications/therapies during the Treatment Period (including the use of paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit or other pain medications within 12 hours prior to the Screening/ Baseline Visit Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit or planned use during the Treatment Period (with the exception of study-provided Rescue Medication [paracetamol/acetaminophen], which is permitted after completion of the first target joint pain assessment on Study Day 4