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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 Year(s) - 89 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Clinical diagnosis of gout.
    2. Confirmation of a gout flare in the target joint.
    3. Acceptable overall medical condition to safely participate in the study and complete all study procedures.
    4. Able and willing to provide written informed consent prior to initiation of any study related procedures.

You may not be eligible for this study if the following are true:

    1. Woman of childbearing potential, or man whose sexual partner(s) is a woman of childbearing potential, who:
      • Is or intends to become pregnant (including use of fertility drugs) while participating in the study;
      • Is lactating/breastfeeding or plans to breastfeed while participating in the study;
      • Is not willing to use an acceptable, highly effective method of contraception until all follow-up procedures are complete.
    2. Presence of any palpable and visible tophi by physical examination.
    3. Presence of rheumatoid arthritis or other acute inflammatory arthritis.
    4. Evidence/suspicion of infectious/septic arthritis.
    5. Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit/Study Day 1 or planned use during the Treatment Period.
    6. History of, or known positive for, HIV, HBsAg, or antibodies to HCV with a positive PCR result for HCV.
    7. Known diagnosis of chronic kidney disease or known history of renal impairment.
    8. Enrollment in any trial and/or use of any investigational medicinal product or device within the immediate 1-year period prior to the Screening/Baseline Visit/Study Day 1.
    9. Enrollment in previous gout studies with dapansutrile.
    10. Active malignancy or recent malignancy with any systemic anti-cancer treatment (e.g., immunotherapy or chemotherapy) within the past 6 months.
    11. Has a serious illness that resulted in hospitalization in the 30 days preceding the Screening/Baseline Visit/Study Day 1.
    12. Has a hypersensitivity or allergy to dapansutrile or other drugs in its class and/or the components of the IMP (dapansutrile tablets or placebo tablets).
    13. Has a hypersensitivity or allergy to paracetamol/acetaminophen.
    14. Is an employee, family member, or student of the Investigator or clinical site.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

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