NCT05658575 · Olatec Therapeutics LLC
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
What this study is about
The purpose of this trial is to investigate the effectiveness and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
View original scientific description
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Interventions
DRUG
Dapansutrile
An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.
OTHER
Placebo Tablet
An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Primary outcome measures
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 IMP
Time frame: 72 hours
Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Glendale, Arizona
- Mesa, Arizona
- Los Angeles, California
- San Diego, California
- Tarzana, California
- DeLand, Florida
- Gainesville, Florida
- Jacksonville, Florida
- Miami, Florida
- Tampa, Florida
- Gainesville, Georgia
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations