Actively Recruiting
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Led by Olatec Therapeutics LLC · Updated on 2026-03-11
300
Participants Needed
40
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects age 18 or older
- Clinical diagnosis of gout confirmed by monosodium urate crystals or imaging evidence in the target joint, or by documented history of gout or 2 or more gout flares in the past 18 months
- Confirmation that gout flare in the target joint began within 96 hours before the baseline visit
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Presence of any palpable and visible tophi by physical exam
- Having 4 or more joints with an acute gout flare at baseline
- Active rheumatoid arthritis or other acute inflammatory arthritis
- Evidence or suspicion of infectious or septic arthritis
- Significant general pain or non-gout joint pain interfering with pain assessment
- Known chronic kidney disease or history of kidney problems
- Positive test for COVID-19 within 4 weeks before baseline, if tested
- Active or recent cancer with systemic anti-cancer treatment
- Allergy or hypersensitivity to OLT1177® or related drugs
- Allergy or hypersensitivity to paracetamol/acetaminophen
- Use of prohibited medications or therapies before or during treatment, including paracetamol/acetaminophen within 4 hours before baseline or other pain medications within 12 hours before baseline, except study-provided rescue medication after Day 4 pain assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Withdrawn
2
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States, 85306
Actively Recruiting
3
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona, United States, 85210
Actively Recruiting
4
American Institute of Research
Los Angeles, California, United States, 90017
Withdrawn
5
TriWest Research Associates
San Diego, California, United States, 92108
Actively Recruiting
6
Valiance Clinical Research - Tarzana
Tarzana, California, United States, 91356
Actively Recruiting
7
Hillcrest Medical Research
DeLand, Florida, United States, 32720
Actively Recruiting
8
SIMEDHealth
Gainesville, Florida, United States, 32607,
Actively Recruiting
9
University of Florida Health Jacksonville
Jacksonville, Florida, United States, 32256
Actively Recruiting
10
Well Pharma Medical Research
Miami, Florida, United States, 33173
Actively Recruiting
11
Clinical Research of West Florida
Tampa, Florida, United States, 33765
Actively Recruiting
12
Arthritis Center of North Georgia - Gainesville
Gainesville, Georgia, United States, 30501
Actively Recruiting
13
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
Withdrawn
14
Advanced Quality Medical Research
Orland Park, Illinois, United States, 60462
Actively Recruiting
15
The Research Group of Lexington
Lexington, Kentucky, United States, 40503
Active, Not Recruiting
16
University of Michigan
Ann Arbor, Michigan, United States, 48109
Withdrawn
17
Montana Medical Research
Missoula, Montana, United States, 59808
Actively Recruiting
18
NYU Langone
New York, New York, United States, 10016
Active, Not Recruiting
19
IMA Clinical Research - Manhattan
New York, New York, United States, 10036
Withdrawn
20
Altoona Research
Duncansville, Pennsylvania, United States, 16635
Withdrawn
21
Lower Country Rheumatology - Summerville
Summerville, South Carolina, United States, 29486
Actively Recruiting
22
Amarillo Center of Clinical Research
Amarillo, Texas, United States, 79124
Actively Recruiting
23
Utah Health - University of Utah Hospital
Salt Lake City, Utah, United States, 84108
Actively Recruiting
24
Clinical Trial Site
Bothell, Washington, United States, 98021
Withdrawn
25
Arthritis Northwest
Spokane, Washington, United States, 99204
Actively Recruiting
26
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
27
Hôpital Saint Philibert
Lomme, France, 59462
Actively Recruiting
28
Hôpital Lariboisière
Paris, France
Actively Recruiting
29
CHU de Rouen - Hôpital Charles-Nicolle
Rouen, France
Actively Recruiting
30
Emek Medical Center
Afula, Israel
Actively Recruiting
31
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
32
Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, Israel, 49100
Actively Recruiting
33
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5266202
Actively Recruiting
34
Reade Research BV
Amsterdam, Netherlands
Actively Recruiting
35
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands, 6229 HX
Actively Recruiting
36
VieCuri Medisch Centrum
Venlo, Netherlands
Actively Recruiting
37
Hospital Universitario san Juan de Alicante
Alicante, Spain, 03010
Withdrawn
38
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
39
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
40
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Actively Recruiting
Research Team
P
Philip Piscitelli
CONTACT
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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