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Dapansutrile tablets for treating acute gout flares

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

Phase2; Phase3 Interventional Olatec Therapeutics LLC · NCT05658575

This study is testing if dapansutrile tablets can help people with acute gout flares feel better compared to a placebo.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorOlatec Therapeutics LLC Industry-sponsored
Locations40 sites (Birmingham, Alabama and 39 other locations)
Trial IDNCT05658575 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of dapansutrile (OLT1177®) tablets in individuals experiencing an acute gout flare. It is a multi-center, Phase 2/3, randomized, double-blind, placebo-controlled study involving up to 300 participants. Eligible subjects will be randomized to receive either dapansutrile or a matching placebo twice daily for 7 days, following an initial loading dose. Participants will be monitored for safety and efficacy, with follow-up visits scheduled throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with a confirmed diagnosis of gout and an acute flare that began within the last 96 hours.

Not a fit: Patients with multiple acute gout flares or visible tophi may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing acute gout flares.

How similar studies have performed: Previous studies have shown promise with NLRP3 inhibitors, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Birmingham, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Gout FlareGout AttackGout FlareGouty ArthritisGoutArthritisJoint Paingout
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.