Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olatec Therapeutics LLC
• Treatments: Dapansutrile

Criteria

Inclusion Criteria:

• Male and female subjects age 18 or older

• Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria

• 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 Screening/Baseline

• Previously diagnosed subjects: Confirmation of gout diagnosis as above OR documented history of the presence of MSU crystals in synovial fluid from the target joint or bursa; OR historical imaging report of urate deposition in the target joint or bursa in medical record

• 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