Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare (NCT05658575)
A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (13 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona
- Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa — Mesa, Arizona
- American Institute of Research — Los Angeles, California
- TriWest Research Associates — San Diego, California
- Valiance Clinical Research - Tarzana — Tarzana, California
- Hillcrest Medical Research — DeLand, Florida
- SIMEDHealth — Gainesville, Florida
- University of Florida Health Jacksonville — Jacksonville, Florida
- Well Pharma Medical Research — Miami, Florida
- Clinical Research of West Florida — Tampa, Florida
- Arthritis Center of North Georgia - Gainesville — Gainesville, Georgia
- Great Lakes Clinical Trials — Chicago, Illinois
- Advanced Quality Medical Research — Orland Park, Illinois
- The Research Group of Lexington — Lexington, Kentucky
- University of Michigan — Ann Arbor, Michigan
- Montana Medical Research — Missoula, Montana
- NYU Langone — New York, New York
- IMA Clinical Research - Manhattan — New York, New York
- Altoona Research — Duncansville, Pennsylvania
- Lower Country Rheumatology - Summerville — Summerville, South Carolina
- Amarillo Center of Clinical Research — Amarillo, Texas
- Utah Health - University of Utah Hospital — Salt Lake City, Utah
- Clinical Trial Site — Bothell, Washington
- Arthritis Northwest — Spokane, Washington
📞 Contact the Study Coordinator
Phone: (833) 652-8321
Email: phil.piscitelli@olatec.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Acute Gout Flare clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.