NCT05658575 Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
| NCT ID | NCT05658575 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Olatec Therapeutics LLC |
| Condition | Acute Gout Flare |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-01-06 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Eligibility Criteria
Inclusion Criteria: * Male and female subjects age 18 or older * Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria: A) 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) Documented history in the target joint or bursa ; or 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 active rheumatoid arthr