Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Description

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

Conditions

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

Study Overview

Study Details

Study overview

The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) 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

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Condition
Acute Gout Flare
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Glendale

Arizona Arthritis & Rheumatology Associates - Glendale, Glendale, Arizona, United States, 85306

Mesa

Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa, Mesa, Arizona, United States, 85210

Los Angeles

American Institute of Research, Los Angeles, California, United States, 90017

San Diego

TriWest Research Associates, San Diego, California, United States, 92108

Tarzana

Valiance Clinical Research - Tarzana, Tarzana, California, United States, 91356

DeLand

Hillcrest Medical Research, DeLand, Florida, United States, 32720

Jacksonville

University of Florida Health Jacksonville, Jacksonville, Florida, United States, 32256

Miami

Well Pharma Medical Research, Miami, Florida, United States, 33173

Tampa

Clinical Research of West Florida, Tampa, Florida, United States, 33765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and female subjects age 18 or older
  • * Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Olatec Therapeutics LLC,

Study Record Dates

2025-10-01