Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Key facts
- Where
- Barcelona and Madrid, SpainSee the 2 sites
- Phase
- Phase 2/3
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitario Infanta LeonorMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Olatec Therapeutics, Inc.
- Trial code
- NCT05658575EU 2024-518844-20-00
- Record updated
- 11 March 2026
- Original description
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.Read full original descriptionShow less
A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Inclusion: Male and female subjects age 18 or older; Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:; 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; 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: 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; 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; 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; 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.