Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acute Gout Flare, Gout Attack, Gout Flare, Gouty Arthritis, Gout, Arthritis, Joint Pain

In brief

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

Key facts

Study ID

NCT05658575

Run by

Olatec Therapeutics, Inc.

People needed

300

Starts

2023-01-06

Expected to finish

2027-01-31

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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 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

Where it is running

• Hospital Universitario Infanta Leonor — Madrid, Spain (enrolling)
• Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa — Mesa, Arizona, United States (enrolling)
• CHU de Rouen - Hôpital Charles-Nicolle — Rouen, France (enrolling)
• Emek Medical Center — Afula, Israel (enrolling)
• Carmel Medical Center — Haifa, Israel (enrolling)
• Rabin Medical Center - Beilinson and Hasharon — Petah Tikva, Israel (enrolling)
• The Chaim Sheba Medical Center — Ramat Gan, Israel (enrolling)
• Reade Research BV — Amsterdam, Netherlands (enrolling)
• Maastricht Universitair Medisch Centrum — Maastricht, Netherlands (enrolling)
• VieCuri Medisch Centrum — Venlo, Netherlands (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitario de La Princesa — Madrid, Spain (enrolling)
• TriWest Research Associates — San Diego, California, United States (enrolling)
• Valiance Clinical Research - Tarzana — Tarzana, California, United States (enrolling)
• Hillcrest Medical Research — DeLand, Florida, United States (enrolling)
• SIMEDHealth — Gainesville, Florida, United States (enrolling)
• University of Florida Health Jacksonville — Jacksonville, Florida, United States (enrolling)
• Well Pharma Medical Research — Miami, Florida, United States (enrolling)
• Clinical Research of West Florida — Tampa, Florida, United States (enrolling)
• Arthritis Center of North Georgia - Gainesville — Gainesville, Georgia, United States (enrolling)
• Advanced Quality Medical Research — Orland Park, Illinois, United States (enrolling)
• Montana Medical Research — Missoula, Montana, United States (enrolling)
• Lower Country Rheumatology - Summerville — Summerville, South Carolina, United States (enrolling)
• Amarillo Center of Clinical Research — Amarillo, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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