Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Launched by OLATEC THERAPEUTICS LLC · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dapansutrile (OLT1177®) to see how well it works and how safe it is for people experiencing an acute gout flare, which is a sudden and painful attack of gout often affecting the joints. Gout is a type of arthritis that can cause severe pain, swelling, and redness in the affected area. The trial is currently looking for participants who are 18 years or older and have a confirmed diagnosis of gout, along with an active gout flare that started within the last four days.

If you decide to participate, you will need to provide written consent and meet certain health criteria. For example, you should not have inflammatory arthritis other than gout or a history of severe kidney problems. Throughout the trial, you will be closely monitored, and you’ll have the chance to share your experience with the medication. This study aims to improve our understanding of how to better manage gout flares, which can be very painful for those who suffer from this condition.

Gender

ALL

Eligibility 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