Treatment of Acute Gout Flare MedDRA version: 21.1 Level: LLT Classification code 10064900 Term: Gout flare System Organ Class: 100000004861
Conditions
Sponsors
Olatec Therapeutics LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female subjects = 18 years of age 2) Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria at the Screening/Baseline Visit/Study Day 1 a. Newly presenting subjects: 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 b. Previously diagnosed subjects: Confirmation of gout diagnosis as per criterion 2a; OR documented history of the presence of MSU crystals in synovial fluid from the target joint or bursa; OR historical imaging report of urate deposition in the target joint or bursa in their medical record 3) Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening/Baseline Visit/Study Day 1, based on the presence (at the Screening/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 4) 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 5) Able and willing to provide written informed consent prior to initiation of any study related procedures 6) Ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes abstaining from the use of Rescue Medication until completion of the first target joint pain assessment on Study Day 4 and abstaining from the use of other prohibited medications, including other pain medications Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1) 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 (see Section 4.10.2 for more details on acceptable forms of contraceptives) 2) Presence of any palpable and visible tophi by physical examination 3) Has = 4 joints with an acute gout flare at the Screening/Baseline Visit/Study Day 1 4) Presence of rheumatoid arthritis or other acute inflammatory arthritis 5) Evidence/suspicion of infectious/septic arthritis 6) 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 7) 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 8) 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 requirements6 9) Use of any prohibited concomitant medications/therapies over the periods defined in Section 4.10.3 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/Study Day 1 or other pain medications within 12 hours prior to the Screening/Baseline Visit/Study Day 1) 10) 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 (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) 11) Meets 2 or more of the criteria for substance use disorder provided in Appendix 1 within 1 year of the Screening/Baseline Visit/Study Day 1 12) 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 13) 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) 14) 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 15) Enrollment in previous gout studies with dapansutrile 16) Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, if tested, within 4 weeks of the Screening/Baseline Visit/Day 1 17) Active malignancy or recent malignancy with any systemic anti-cancer treatme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: 1. To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points post initial loading dose of IMP 2. To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion) 3. To assess and compare changes in relevant circulating inflammatory biomarkers between dapansutrile and placebo 4. To characterize the population pharmacokinetics (PK) of dapansutrile and exposure response relationship for efficacy and safety 5. To assess the safety and tolerability of dapansutrile compared to placebo;Primary end point(s): Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo.;Timepoint(s) of evaluation of this end point: at 72 hours post initial loading dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in the subject-assessed pain intensity score (100-mm VAS) in the target joint at 12, 24, 36, 48, and 60 hours post initial loading dose, and on Study Day 8 and Study Day 15 • Subject-assessed PGART on Study Day 8 • Change from baseline in the Investigator-assessed Target Joint Score (tenderness, swelling, erythema, warmth, and range of motion) at scheduled assessments through Study Day 15 • Investigator-assessed IGART at scheduled assessments through Study Day 8;Timepoint(s) of evaluation of this end point: Refer to protocol end point timepoints | — |
Countries
France, Netherlands, Spain, United States
Contacts
Public ContactClinical Trials Inquiries
Olatec Therapeutics LLC
Outcome results
None listed