Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
NCT ID: NCT05658575
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2023-01-06
2026-08-31
Brief Summary
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Detailed Description
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Subjects presenting with acute gout flare that began within 96 hours prior to the Baseline/Day 1 visit will be evaluated for eligibility. Subjects who are determined to be eligible will be randomized into either an active treatment arm (2/3 of the subjects enrolled) or the placebo arm (1/3 of the subjects enrolled).
Eligible subjects who are randomized into the study will also be provided with rescue medication at the Baseline/Day 1 Visit. No other pain medications, anti-inflammatory drugs (e.g., steroids or nonsteroidal anti-inflammatory drugs), or treatments for gout flare are allowed during the Treatment Period.
During the Treatment Period, subjects will return to the clinic trial site on Day 4 and, following the 7-day Treatment Period, subjects will return to the clinical trial site on Day 8, and then Day 15 with safety data collected through Day 36.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapansutrile
An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Dapansutrile
An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Placebo Tablet
An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Placebo Tablet
An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Interventions
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Dapansutrile
An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Placebo Tablet
An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Olatec Therapeutics LLC
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona, United States
American Institute of Research
Los Angeles, California, United States
TriWest Research Associates
San Diego, California, United States
Valiance Clinical Research - Tarzana
Tarzana, California, United States
Hillcrest Medical Research
DeLand, Florida, United States
SIMEDHealth
Gainesville, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Well Pharma Medical Research
Miami, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Arthritis Center of North Georgia - Gainesville
Gainesville, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Advanced Quality Medical Research
Orland Park, Illinois, United States
The Research Group of Lexington
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
Montana Medical Research
Missoula, Montana, United States
NYU Langone
New York, New York, United States
IMA Clinical Research - Manhattan
New York, New York, United States
Altoona Research
Duncansville, Pennsylvania, United States
Lower Country Rheumatology - Summerville
Summerville, South Carolina, United States
Amarillo Center of Clinical Research
Amarillo, Texas, United States
Utah Health - University of Utah Hospital
Salt Lake City, Utah, United States
Clinical Trial Site
Bothell, Washington, United States
Arthritis Northwest
Spokane, Washington, United States
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, , France
Hôpital Saint Philibert
Lomme, , France
Hôpital Lariboisière
Paris, , France
CHU de Rouen - Hôpital Charles-Nicolle
Rouen, , France
Emek Medical Center
Afula, , Israel
Carmel Medical Center
Haifa, , Israel
Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Reade Research BV
Amsterdam, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
Hospital Universitario san Juan de Alicante
Alicante, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Clinical Contact
Role: primary
Clinical Contact
Role: primary
Clinical Contact
Role: primary
Clinical Contact
Role: primary
Clinical Contact
Role: primary
Clinical Contact
Role: primary
Clinical Site
Role: primary
Other Identifiers
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OLT1177-08
Identifier Type: -
Identifier Source: org_study_id
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