Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Last updated: December 2, 2024
Sponsor: Olatec Therapeutics LLC
Overall Status: Active - Recruiting

Phase

2/3

Condition

Musculoskeletal Diseases

Joint Injuries

Chronic Pain

Treatment

Placebo Tablet

Dapansutrile

Clinical Study ID

NCT05658575
OLT1177-08
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects age 18 or older

  • Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout ClassificationCriteria:

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 tothe Screening/Baseline Visit

  • Provide written informed consent and understand and comply with all trialrequirements

Exclusion

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 wouldinterfere 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 inthe protocol or planned use of any prohibited concomitant medications/therapiesduring the Treatment Period (including the use of paracetamol/acetaminophen within 4hours prior to the Screening/Baseline Visit or other pain medications within 12hours prior to the Screening/ Baseline Visit

  • Use of any product containing paracetamol/acetaminophen within 4 hours prior to theScreening/Baseline Visit or planned use during the Treatment Period (with theexception of study-provided Rescue Medication [paracetamol/acetaminophen], which ispermitted after completion of the first target joint pain assessment on Study Day 4

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo Tablet
Phase: 2/3
Study Start date:
January 06, 2023
Estimated Completion Date:
October 01, 2025

Study 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 Screening/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.

Connect with a study center

  • Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • Hôpital Saint Philibert

    Lomme, 59462
    France

    Active - Recruiting

  • Hôpital Lariboisière

    Paris,
    France

    Active - Recruiting

  • CHU de Rouen - Hôpital Charles-Nicolle

    Rouen,
    France

    Active - Recruiting

  • Emek Medical Center

    Afula,
    Israel

    Site Not Available

  • Reade Research BV

    Amsterdam,
    Netherlands

    Site Not Available

  • VieCuri Medisch Centrum

    Venlo,
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital general Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Clinical Trial Site

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Clinical Trial Site

    Glendale, Arizona 85306
    United States

    Active - Recruiting

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

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Clinical Trial Site

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Clinical Trial Site

    El Cajon, California 90017
    United States

    Site Not Available

  • Clinical Trial Site

    Lexington, California 40503
    United States

    Active - Recruiting

  • American Institute of Research

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Clinical Trial Site

    Los Angeles, California 92108
    United States

    Active - Recruiting

  • TriWest Research Associates

    San Diego, California 92108
    United States

    Active - Recruiting

  • Clinical Trial Site

    Summerville, California 29486
    United States

    Active - Recruiting

  • Clinical Trial Site

    Tarzana, California 91356
    United States

    Active - Recruiting

  • Valiance Clinical Research - Tarzana

    Tarzana, California 91356
    United States

    Active - Recruiting

  • Clinical Trial Site

    DeBary, Florida 32713
    United States

    Active - Recruiting

  • Omega Research

    DeBary, Florida 32713
    United States

    Site Not Available

  • Clinical Trial Site

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Hillcrest Medical Research

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Clinical Trial Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • University of Florida Health Jacksonville

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Well Pharma Medical Research

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Clinical Research of West Florida

    Tampa, Florida 33765
    United States

    Active - Recruiting

  • Arthritis Center of North Georgia - Gainesville

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Clinical Trial Site

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Clinical Trial Site

    Orland Park, Illinois 60462
    United States

    Active - Recruiting

  • The Research Group of Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Clinical Trial Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Clinical Trial Site

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • Montana Medical Research

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • Clinical Trial Site

    New York, New York 10016
    United States

    Active - Recruiting

  • IMA Clinical Research - Manhattan

    New York, New York 10036
    United States

    Active - Recruiting

  • NYU Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • Altoona Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Trial Site

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Lower Country Rheumatology - Summerville

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • Amarillo Center of Clinical Research

    Amarillo, Texas 79124
    United States

    Active - Recruiting

  • Clinical Trial Site

    Amarillo, Texas 79124
    United States

    Active - Recruiting

  • Utah Health - University of Utah Hospital

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • Clinical Trial Site

    Bothell, Washington 98021
    United States

    Site Not Available

  • Arthritis Northwest

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Clinical Trial Site

    Spokane, Washington 99204
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.