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NCT05658575 | RECRUITING | Acute Gout Flare

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Sponsor:

Olatec Therapeutics LLC

Brief Summary:

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

Condition or disease

Acute Gout Flare

Gout Attack

Gout Flare

Gouty Arthritis

Gout

Arthritis

Joint Pain

Intervention/treatment

Dapansutrile

Placebo Tablet

Phase

PHASE2

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-01-06
Estimated Primary Completion Date : 2025-11-01
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Location Details

NCT05658575

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

WITHDRAWN

United States, alabama

University of Alabama at Birmingham

Birmingham, alabama, United States, 35294

RECRUITING

United States, Arizona

Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, arizona, United States, 85306

RECRUITING

United States, Arizona

Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa

Mesa, arizona, United States, 85210

WITHDRAWN

United States, California

American Institute of Research

Los Angeles, California, United States, 90017

RECRUITING

United States, California

TriWest Research Associates

San Diego, California, United States, 92108

RECRUITING

United States, California

Valiance Clinical Research - Tarzana

Tarzan, California, United States, 91356

RECRUITING

United States, Florida

Hillcrest Medical Research

DeLand, florida, United States, 32720

RECRUITING

United States, Florida

University of Florida Health Jacksonville

Jacksonville, florida, United States, 32256

RECRUITING

United States, Florida

Well Pharma Medical Research

Miami, florida, United States, 33173

RECRUITING

United States, Florida

Clinical Research of West Florida

Tampa, florida, United States, 33765

RECRUITING

United States, Georgia

Arthritis Center of North Georgia - Gainesville

Gainesville, Georgia, United States, 30501

WITHDRAWN

United States, Illinois

Great Lakes Clinical Trials

Chicago, Illinois, United States, 60640

RECRUITING

United States, Illinois

Advanced Quality Medical Research

Orland Park, Illinois, United States, 60462

RECRUITING

United States, Kentucky

The Research Group of Lexington

Lexington, Kentucky, United States, 40503

RECRUITING

United States, road cancer

University of Michigan

Ann Arbor, road cancer, United States, 48109

RECRUITING

United States, Montana

Montana Medical Research

Missoula, Montana, United States, 59808

RECRUITING

United States, New York

HOW

New York, New York, United States, 10016

WITHDRAWN

United States, New York

IMA Clinical Research - Manhattan

New York, New York, United States, 10036

WITHDRAWN

United States, Pennsylvania

Altoona Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, South Carolina

Lower Country Rheumatology - Summerville

Summerville, South Carolina, United States, 29486

RECRUITING

United States, Texas

Amarillo Center of Clinical Research

Yellow, Texas, United States, 79124

RECRUITING

United States, Utah

Utah Health - University of Utah Hospital

Salt Lake City, Utah, United States, 84108

WITHDRAWN

United States, Washington

Clinical Trial Site

Bothell, Washington, United States, 98021

RECRUITING

United States, Washington

Arthritis Northwest

Spokane, Washington, United States, 99204

RECRUITING

France,

Bordeaux University Hospital Center - Pellegrin Hospital

Bordeaux, France, 33076

RECRUITING

France,

Saint Philibert Hospital

Pocket, France, 59462

RECRUITING

France,

Lariboisière Hospital

Paris, France,

RECRUITING

France,

Rouen University Hospital - Charles-Nicolle Hospital

Rouen, France,

RECRUITING

Israel,

Emek Medical Center

Afula, Israel,

RECRUITING

Israel,

Carmel Medical Center

Haifa, Israel, 3436212

RECRUITING

Israel,

Rabin Medical Center - Beilinson and Hasharon

Petah Pumpkin, Israel, 49100

RECRUITING

Israel,

The Chaim Sheba Medical Center

Ramat Gan, Israel, 5266202

RECRUITING

Netherlands,

Reade Research BV

Amsterdam, Netherlands,

RECRUITING

Netherlands,

Maastricht University Medical Center

Maastricht, Netherlands, 6229 HX

RECRUITING

Netherlands,

VieCuri Medical Center

Venlo, Netherlands,

RECRUITING

Spain,

San Juan University Hospital in Alicante

Alicante, Spain, 03010

RECRUITING

Spain,

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08025

RECRUITING

Spain,

La Princesa University Hospital

Madrid, Spain, 28006

RECRUITING

Spain,

Infanta Leonor University Hospital

Madrid, Spain, 28031