Frontlight ResearchEarly access
Taking people in NetherlandsPhase 2/3
Dapansutrile tablets for adults having an acute gout flare
Tests dapansutrile tablets against placebo in adults with a sudden gout flare.
Key facts
- Who runs it
- Olatec Therapeutics, Inc.
- Where
- Amsterdam, Leeuwarden, Maastricht, and Venlo, NetherlandsSee the 4 sitesAlso in 4 other countries, 33 sites
- Registry title
- Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 300 people, planned
- Started
- 6 Jan 2023
- Expected to end
- 31 Jan 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Dapansutrile
- Placebo Tablet
- Record updated
- 11 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with gout who have a gout flare in one joint. The flare must have started within 96 hours before the first visit.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Acute gout flare in a target joint, starting within 96 hours before the screening visit. Gout must be confirmed by urate crystals in joint fluid or by imaging, or by a documented history in that joint, or by 2 or more gout flares in the previous 18 months. Fewer than 4 joints may be flaring.
- Earlier treatment
- No paracetamol/acetaminophen within 4 hours, and no other pain medicines within 12 hours, before the screening visit. No other medicines banned by the protocol.
Main reasons for not taking part
- Tophi (lumps of urate crystals) that can be seen or felt
- 4 or more joints with a gout flare, rheumatoid arthritis, other inflammatory arthritis, or joint infection
- Chronic kidney disease or a history of kidney problems
- Active cancer, or recent cancer treated with anti-cancer medicine
- Allergy to OLT1177® or similar drugs, or to paracetamol/acetaminophen
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Netherlands
Also in 4 other countries, 33 sites
- Reade AmsterdamAmsterdam, NetherlandsTaking people
- Frisius MCLeeuwarden, NetherlandsTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, NetherlandsTaking people
About the trial
What the trial wants to find out
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
The 2 groups in the trial
- DapansutrileTreatment being tested
An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.
- Placebo TabletPlacebo, for comparison
An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Dapansutrile tablets for adults having an acute gout flareGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 11 March 2026