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New treatment option for Acute Gout Flare
Official title Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
ClinicalTrials.gov ID: NCT05658575
What this study is testing
What is Dapansutrile?
Dapansutrile is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute gout flare.
Also referred to as OLT1177.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female people 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...
- 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
You likely can't join if
- 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...
- Known diagnosis of chronic kidney disease or known history of renal impairment
See the full eligibility criteria
- Male and female people 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Tarzana, California, United States
- DeLand, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Gainesville, Georgia, United States
- Chicago, Illinois, United States
- Orland Park, Illinois, United States
- Lexington, Kentucky, United States
- Ann Arbor, Michigan, United States
- Missoula, Montana, United States
- New York, New York, United States
- Duncansville, Pennsylvania, United States
- Summerville, South Carolina, United States
+ 18 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Glendale, Arizona, United States; Mesa, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; Tarzana, California, United States and 32 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.