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NCT05658575PHASE2, PHASE3Recruiting

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Olatec Therapeutics, Inc.

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

Inclusion Criteria: * Male and female subjects age 18 or older * 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: * Presence of any palpable and visible tophi by physical examination * 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

Interventions

DRUG

Dapansutrile

OTHER

Placebo Tablet

Interested in This Trial?

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Conditions

Acute Gout FlareGout AttackGout FlareGouty ArthritisGoutArthritisJoint Pain

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