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Study of Dapansutrile for Acute Gout Flares

This study is testing a medication called dapansutrile to see if it can effectively reduce joint pain during an acute gout flare (a sudden, severe attack of gout). You may be eligible if you are 18 or older and have a confirmed diagnosis of gout, including evidence of gout crystals in your joint fluid or imaging. The study will compare dapansutrile to a placebo (an inactive pill that looks like the study drug) to see if dapansutrile helps more with pain at 72 hours after starting treatment. Up to 300 people will participate. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either dapansutrile or a placebo, and neither you nor your doctor will know which you are receiving. About 300 participants will be enrolled.
What's involved
You would take dapansutrile or placebo tablets for 7 days, starting with a loading dose and then twice daily. You would also have clinic visits on Day 4, Day 8, and Day 15.
Compensation
Not stated in the trial record.
Follow-up
Safety data will be collected through Day 36 after treatment begins.

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NCT05658575

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Recruiting
PHASE2Ages 18+InterventionalTreatment
Olatec Therapeutics, Inc.
~300 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:DapansutrilePlacebo Tablet

At a glance

Recruiting sites
30 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP
Measured over 72 hours

Conditions

Acute Gout Flare
Gout Attack
Gout Flare
Gouty Arthritis
Gout
Arthritis
Joint Pain

Explore related trials

Gout

Where it's being run

40 sites across 19 states
Florida5
France4
Israel4
Spain4
California3
Netherlands3
Arizona2
Illinois2

Who to contact

Philip Piscitelli
[email protected]
+1 833-652-8321 · ext. 115
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male and female subjects age 18 or older
Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:
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

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
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

What this trial measures

  • To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP72 hours

    Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.