RecruitingPhase 2Phase 3NCT05658575

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

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

Sponsor

Olatec Therapeutics LLC

Enrollment

300 participants

Start Date

Jan 6, 2023

Study Type

INTERVENTIONAL

Conditions

Joint Pain Arthritis Gout Gouty Arthritis Gout Flare Gout Attack Acute Gout Flare

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests dapansutrile (OLT1177), an experimental anti-inflammatory pill, for treating an acute gout flare. Gout causes sudden, severe joint pain and swelling when uric acid crystals build up in joints. Unlike current gout treatments (like colchicine or steroids), dapansutrile targets a specific part of the inflammatory pathway called the NLRP3 inflammasome. You may be eligible if: - You are 18 or older - You have a confirmed gout diagnosis and are currently experiencing a gout flare in a specific joint that started within the past 96 hours - Your gout has been confirmed by crystal analysis, imaging, or a history of 2 or more flares in the past 18 months You may NOT be eligible if: - You have visible tophi (hard uric acid deposits under the skin) - You have 4 or more joints flaring at once - You have active rheumatoid arthritis, infectious arthritis, or chronic kidney disease - You have tested positive for COVID-19 in the past 4 weeks - You have an active cancer - You are allergic to dapansutrile or acetaminophen/paracetamol - You have recently taken pain medications before the baseline visit Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapansutrile

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.

OTHERPlacebo 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.

Locations(40)

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

View Full Details on ClinicalTrials.gov

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NCT05658575

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Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(40)

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