Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05658575

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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Withdrawn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

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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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