Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlatec Therapeutics LLC
About this trial
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
Qualifiers
Male and female subjects age 18 or older
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
Disqualifiers
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 arthritis or other acute inflammatory arthritis
Evidence/suspicion of infectious/septic arthritis
Trial design
Treatments tested in this trial
- Dapansutrile
- Placebo Tablet
Treatment groups
300 Participants
are divided into 2 treatment groupsLocations
40France
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin33076, Bordeaux France
Hôpital Saint Philibert59462, Lomme France
Hôpital Lariboisière Paris France
CHU de Rouen - Hôpital Charles-Nicolle Rouen France
Sponsors and collaborators
Olatec Therapeutics LLC
Lead sponsor
Source ClinicalTrials.gov