Dapansutrile tablets for treating acute gout flares

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Arthritis & Rheumatology Associates - Glendale
  Glendale, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
  Mesa, Arizona, United States Recruiting
• TriWest Research Associates
  San Diego, California, United States Recruiting
• Valiance Clinical Research - Tarzana
  Tarzana, California, United States Recruiting
• Hillcrest Medical Research
  DeLand, Florida, United States Recruiting
• SIMEDHealth
  Gainesville, Florida, United States Recruiting

Study contacts

• Study coordinator: Philip Piscitelli
• Email: phil.piscitelli@olatec.com
• Phone: +1 833-652-8321

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Purified Cortrophin® Gel for treating acute gout flares at two dose levels

  This study will try two single injections (40 U and 80 U) of Purified Cortrophin® Gel to see which dose better and more quickly reduces pain in adults having an acute gout flare.

  Recruiting Phase 4 Massachusetts General Hospital · Boston, Massachusetts · NCT07346079

• Pharmacist-led urate-lowering care to reach target in gout patients

  This study tests whether a pharmacist-led, telehealth approach to ULT management helps veterans with gout reach uric acid goals and reduce flare burden compared with usual care.

  Recruiting at 5 sites VA Office of Research and Development · Omaha, Nebraska and 4 other locations · NCT06887452

• Examining the effects of different exercise levels on arthritis symptoms

  This study tests how different amounts of exercise can help people with arthritis feel better over six months.

  Recruiting University of South Carolina · Columbia, South Carolina · NCT06880653

• Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

  This observational study tests how pain is experienced and measured in people with rheumatic diseases compared with healthy volunteers.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07829497

• Hydroxychloroquine for AIMSS in breast cancer patients on aromatase inhibitors

  This study tests whether hydroxychloroquine can reduce joint pain in people with breast cancer who are taking aromatase inhibitors and have AIMSS.

  Recruiting Phase 2 Indiana University · Indianapolis, Indiana · NCT07825454

• Collagen and omega-3 supplements in middle-aged women

  This study tests whether taking collagen and omega-3s together improves joint pain, fatigue, sleep, and overall wellbeing in healthy women aged 35–65 compared with a placebo over 8 weeks.

  Recruiting Loughborough University · Loughborough · NCT07740967

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.