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Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
EU CTIS ID: 2024-518844-20-00
What this study is testing
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 Investigational Medicinal Product (IMP)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female subjects ≥ 18 years of age
- Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria at the Screening Visit or Baseline Visit/Study Day 1 (i.e., subject must have at least 8 points or meet Sufficient Criterion). In addition: a. Diagnosis of gout must be confirmed in the target joint at the Baseline Visit/Study Day 1 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 OR b. Documented history of gout diagnosis in the target joint or bursa; or a 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 Baseline Visit/Study Day 1, based on the presence (at the Baseline Visit/Study Day 1) of subject-reported target joint pain at rest of ≥ 50 mm on a 0 to 100-mm VAS and at least two of the following criteria in the target joint: a. Subject-reported flare b. Subject-reported warm joint c. Subject-reported swollen joint
- Acceptable overall medical condition to safely participate in the study and complete all study procedures (with specific regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator
- Able and willing to provide written informed consent prior to initiation of any studyrelated procedures
- Ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes understanding restrictions regarding the use of Rescue Medication, Escape Medication and other prohibited medications, including other pain medications
You likely can't join if
- Woman of childbearing potential, or man whose sexual partner(s) is a woman of childbearing potential, who: a. Is or intends to become pregnant (including use of fertility drugs) while participating in the study (through the Study Day 36 Follow-up call) b. Is lactating/breastfeeding or plans to breastfeed while participating in the study (female subjects only) c. Is not willing to use an acceptable, highly effective method of contraception until all follow-up procedures are complete
- Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Baseline Visit/Study Day 1 or planned use during the Treatment Period (with the exception of Sponsor-provided Rescue Medication [paracetamol/acetaminophen], which is permitted after completion of the target joint pain assessment on Study Day 4 (that is, ~ 72 hours after first dose)
- Meets 2 or more of the criteria for substance use disorder provided in Appendix 1 of the protocol within 1 year of the Baseline Visit/Study Day 1
- History of, or known positive for, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus (HCV) with a positive polymerase chain reaction (PCR) result for HCV
- Known diagnosis of chronic kidney disease or known history of renal impairment (e.g., estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m2)
- Enrollment in an interventional trial and/or use of any investigational medicinal product or device within 90 days or five (5) half-lives of the investigational agent, whichever is longer, prior to the Screening Visit
See the full eligibility criteria
Who can join
- Male and female subjects ≥ 18 years of age
- Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria at the Screening Visit or Baseline Visit/Study Day 1 (i.e., subject must have at least 8 points or meet Sufficient Criterion). In addition: a. Diagnosis of gout must be confirmed in the target joint at the Baseline Visit/Study Day 1 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 OR b. Documented history of gout diagnosis in the target joint or bursa; or a 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 Baseline Visit/Study Day 1, based on the presence (at the Baseline Visit/Study Day 1) of subject-reported target joint pain at rest of ≥ 50 mm on a 0 to 100-mm VAS and at least two of the following criteria in the target joint: a. Subject-reported flare b. Subject-reported warm joint c. Subject-reported swollen joint
- Acceptable overall medical condition to safely participate in the study and complete all study procedures (with specific regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator
- Able and willing to provide written informed consent prior to initiation of any studyrelated procedures
- Ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes understanding restrictions regarding the use of Rescue Medication, Escape Medication and other prohibited medications, including other pain medications
What rules you out
- Woman of childbearing potential, or man whose sexual partner(s) is a woman of childbearing potential, who: a. Is or intends to become pregnant (including use of fertility drugs) while participating in the study (through the Study Day 36 Follow-up call) b. Is lactating/breastfeeding or plans to breastfeed while participating in the study (female subjects only) c. Is not willing to use an acceptable, highly effective method of contraception until all follow-up procedures are complete
- Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Baseline Visit/Study Day 1 or planned use during the Treatment Period (with the exception of Sponsor-provided Rescue Medication [paracetamol/acetaminophen], which is permitted after completion of the target joint pain assessment on Study Day 4 (that is, ~ 72 hours after first dose)
- Meets 2 or more of the criteria for substance use disorder provided in Appendix 1 of the protocol within 1 year of the Baseline Visit/Study Day 1
- History of, or known positive for, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus (HCV) with a positive polymerase chain reaction (PCR) result for HCV
- Known diagnosis of chronic kidney disease or known history of renal impairment (e.g., estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m2)
- Enrollment in an interventional trial and/or use of any investigational medicinal product or device within 90 days or five (5) half-lives of the investigational agent, whichever is longer, prior to the Screening Visit
- Enrollment in previous gout studies with dapansutrile
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, if tested, within 4 weeks of the Baseline Visit/Study Day 1
- Active malignancy or recent malignancy with any systemic anti-cancer treatment (e.g., immunotherapy or chemotherapy) within the past 6 months
- Has a serious illness that resulted in hospitalization in the 30 days preceding the Baseline Visit/Study Day 1
- 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)
- Presence of any palpable and visible tophi by physical examination
- Has a hypersensitivity or allergy to paracetamol/acetaminophen
- Is an employee, family member, or student of the Investigator or clinical site
- Has ≥ 4 joints with an acute gout flare at the Baseline Visit/Study Day 1
- Presence of pain due to 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, in the opinion of the Investigator
- Known history of any clinically significant or unstable medical condition or any other disorder, condition, or circumstance (including secondary pain, or recreational or medical use of substances that may alter pain perception such as cannabidiol [CBD]- and tetrahydrocannabinol [THC]-containing substances, psilocybin, etc.) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
- Any other concomitant medical or psychiatric conditions, diseases, or prior surgeries that, in the opinion of the Investigator, would impair the subject from safely participating in the trial and/or completing protocol requirements
- Use of any prohibited concomitant medications/therapies over the periods defined in Section 4.10.3 of 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 Baseline Visit/Study Day 1 or other pain medications within 12 hours prior to the Baseline Visit/Study Day 1)
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.