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Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

RecruitingPhase 2/3

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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

What is being tested

Sponsor: Olatec Therapeutics, Inc. · Participants: 300 · Started: Jan 6, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05658575

Locations in the U.S.

ArizonaArizona Arthritis & Rheumatology Associates - Glendale, Glendale
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa, Mesa
CaliforniaTriWest Research Associates, San Diego
Valiance Clinical Research - Tarzana, Tarzana
FloridaHillcrest Medical Research, DeLand
SIMEDHealth, Gainesville
University of Florida Health Jacksonville, Jacksonville
Well Pharma Medical Research, Miami
Clinical Research of West Florida, Tampa
GeorgiaArthritis Center of North Georgia - Gainesville, Gainesville
IllinoisAdvanced Quality Medical Research, Orland Park
MontanaMontana Medical Research, Missoula
South CarolinaLower Country Rheumatology - Summerville, Summerville
TexasAmarillo Center of Clinical Research, Amarillo
UtahUtah Health - University of Utah Hospital, Salt Lake City
WashingtonArthritis Northwest, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.