Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Olatec Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with an acute gout flare. Participants will take dapansutrile tablets and help researchers learn about its effects on gout symptoms.
Are You a Good Fit for This Trial?
Must not be takingParacetamol
Rules you outChronic kidney diseaseActive malignancy
You may be able to join if
I am 18 years old or older
I have a clinical diagnosis of gout
I confirm that my gout flare began within the last 96 hours
I can provide written consent to participate
You may not be able to join if
I have visible tophi on physical examination
I have 4 or more joints with an acute gout flare
I have rheumatoid arthritis or other inflammatory arthritis
I suspect I have an infection in my joints
I have chronic kidney disease or renal impairment
I tested positive for COVID-19 in the last 4 weeks
I have an active or recent cancer diagnosis
I am allergic to dapansutrile or paracetamol
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Trial Locations
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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…
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
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