Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Start Date
1/6/2023
Completion Date
1/31/2027
Summary
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Detailed Description
This is a multi-center Phase 2/3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177®), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare. Up to 300 eligible subjects will be randomized 2:1 to one of two treatment arms to receive either dapansutrile tablets or matching placebo twice daily for 7 days. An initial loading dose on Study Day 1 will be followed by a twice daily maintenance dosing regimen. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Dapansutrile
Placebo Tablet
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona 85306
United States
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona 85210
United States
American Institute of Research
Los Angeles, California 90017
United States
TriWest Research Associates
San Diego, California 92108
United States
Valiance Clinical Research - Tarzana
Tarzana, California 91356
United States
Hillcrest Medical Research
DeLand, Florida 32720
United States
SIMEDHealth
Gainesville, Florida 32607,
United States
University of Florida Health Jacksonville
Jacksonville, Florida 32256
United States
Well Pharma Medical Research
Miami, Florida 33173
United States
Clinical Research of West Florida
Tampa, Florida 33765
United States
Arthritis Center of North Georgia - Gainesville
Gainesville, Georgia 30501
United States
Great Lakes Clinical Trials
Chicago, Illinois 60640
United States
Advanced Quality Medical Research
Orland Park, Illinois 60462
United States
The Research Group of Lexington
Lexington, Kentucky 40503
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Montana Medical Research
Missoula, Montana 59808
United States
NYU Langone
New York, New York 10016
United States
IMA Clinical Research - Manhattan
New York, New York 10036
United States
Altoona Research
Duncansville, Pennsylvania 16635
United States
Lower Country Rheumatology - Summerville
Summerville, South Carolina 29486
United States
Amarillo Center of Clinical Research
Amarillo, Texas 79124
United States
Utah Health - University of Utah Hospital
Salt Lake City, Utah 84108
United States
Clinical Trial Site
Bothell, Washington 98021
United States
Arthritis Northwest
Spokane, Washington 99204
United States
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, 33076
France
Hôpital Saint Philibert
Lomme, 59462
France
Hôpital Lariboisière
Paris,
France
CHU de Rouen - Hôpital Charles-Nicolle
Rouen,
France
Emek Medical Center
Afula,
Israel
Carmel Medical Center
Haifa, 3436212
Israel
Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, 49100
Israel
The Chaim Sheba Medical Center
Ramat Gan, 5266202
Israel
Reade Research BV
Amsterdam,
Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
Netherlands
VieCuri Medisch Centrum
Venlo,
Netherlands
Hospital Universitario san Juan de Alicante
Alicante, 03010
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Hospital Universitario de La Princesa
Madrid, 28006
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain