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RecruitingPhase 2/Phase 3

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Olatec Therapeutics, Inc. · NCT05658575

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
300
US sites recruiting
16
Study start
January 6, 2023
Record last updated
March 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.

Being studied: Dapansutrile; Placebo Tablet

Conditions: Acute Gout Flare; Gout Attack; Gout Flare; Gouty Arthritis; Gout; Arthritis; Joint Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale, AZ 85306

    Site contact: Rebecca Martinez · 480-350-7655 · rebecca.martinez@azarthritis.com

  • Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa

    Mesa, AZ 85210

    Site contact: Rebecca 480-350-7655 · 480-350-7655 · rebecca.martinez@azarthritis.com

  • TriWest Research Associates

    San Diego, CA 92108

    Site contact: Lennette Fontelar · 619-334-4735 · lfontelar@triwestresearch.com

  • Valiance Clinical Research - Tarzana

    Tarzana, CA 91356

    Site contact: Gail Ma · 818-938-9167 · g.ma@valianceclinicalresearch.com

  • Hillcrest Medical Research

    DeLand, FL 32720

    Site contact: Larry Moulder · 321-999-7616 · lmoulder@hillcrestmedicalresearch.com

  • SIMEDHealth

    Gainesville, FL 32607,

    Site contact: Brandy Donahue-Quails · 352-333-3885 · Bdonahue-quails@simedresearch.com

  • University of Florida Health Jacksonville

    Jacksonville, FL 32256

    Site contact: Shannon Lloyd · 904-633-0071 · shannon.lloyd@ufhealth.org

  • Well Pharma Medical Research

    Miami, FL 33173

    Site contact: Ramon Perez Landaburo · 305-665-4818 · rperez@wpharma.com

  • Clinical Research of West Florida

    Tampa, FL 33765

    Site contact: Jocelyn Evans · 813-870-1292 · jevans@crwf.com

  • Arthritis Center of North Georgia - Gainesville

    Gainesville, GA 30501

    Site contact: Cindy Valenzuela · 770-531-3711 · cvalenzuela@southeasternra.com

  • Advanced Quality Medical Research

    Orland Park, IL 60462

    Site contact: Selahaddin Hocaoglu · 312-823-6800 · selahaddin@m1-health.com

  • Montana Medical Research

    Missoula, MT 59808

    Site contact: Eve Hickey · 406-549-1124 · ehickey@montanamedicalresearch.com

  • Lower Country Rheumatology - Summerville

    Summerville, SC 29486

    Site contact: Eleanor Gardzalla · 843-572-4840 · egardzalla@articularishealthcare.com

  • Amarillo Center of Clinical Research

    Amarillo, TX 79124

    Site contact: Vallen White · 806-352-2453 · vwhite@allergyarts.com

  • Utah Health - University of Utah Hospital

    Salt Lake City, UT 84108

    Site contact: Julieanne Hall · 801-213-1558 · julieanne.hall@hsc.utah.edu

  • Arthritis Northwest

    Spokane, WA 99204

    Site contact: Terri Cone · 509-838-6500 · tcone@arthritisnw.com

Study contacts (from the official record)

  • Philip Piscitelli · +1 833-652-8321 · phil.piscitelli@olatec.com
  • Clinical Operations · clinops@olatec.com
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Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare (NCT05658575) | Bored Studies