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NCT05586958 | RECRUITING | Gout

Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
Sponsor:

LG Than

Brief Summary:

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Condition or disease

Gout

Hyperuricemia

Gout Flare

Tophi

Intervention/treatment

Tigulixostat

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 350 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia
Actual Study Start Date : 2022-10-25
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male or female subjects between the ages of 18 85 years, inclusive.
  • * Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
  • * Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
  • * Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).
Exclusion Criteria
  • * Subjects with secondary hyperuricemia, enzymatic defects.
  • * Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
  • * Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
  • * Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
  • * Subjects with a history of xanthinuria (elevated levels of xanthine in the urine) and rheumatoid arthritis
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Location Details

NCT05586958

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

RECRUITING

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

RECRUITING

United States, Alabama

Syed Research Consultants, LLC

Muscle Shoals, Alabama, United States, 35661

RECRUITING

United States, California

Medvin Clinical Research

Covina, California, United States, 91722

RECRUITING

United States, Florida

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

Herco Medical and Research Center, Inc

Coral Gables, Florida, United States, 33134

RECRUITING

United States, Florida

Direct Helpers Research Center

Hialeah, Florida, United States, 33012

RECRUITING

United States, Florida

Research Institute of South Florida, Inc.

Miami, Florida, United States, 33173

RECRUITING

United States, Florida

Clinical Research of West Florida, Inc.

Tampa, Florida, United States, 33606

RECRUITING

United States, Florida

Conquest Research, LLC

Winter Park, Florida, United States, 32789

RECRUITING

United States, Georgia

Vista Clinical Research, LLC

Newnan, Georgia, United States, 30265

RECRUITING

United States, Idaho

Velocity Clinical Research

Meridian, Idaho, United States, 83642

RECRUITING

United States, Illinois

Healthcare Research Network II, LLC

Flossmoor, Illinois, United States, 60422

RECRUITING

United States, Kentucky

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, United States, 40509

RECRUITING

United States, Kentucky

L-MARC Research Center

Louisville, Kentucky, United States, 40213

RECRUITING

United States, Maryland

MD Medical Research

Oxon Hill, Maryland, United States, 20745

RECRUITING

United States, Mississippi

Elite Clinical Research, LLC

Jackson, Mississippi, United States, 39202

RECRUITING

United States, Mississippi

Olive Branch Family Medical Center

Olive Branch, Mississippi, United States, 38654

RECRUITING

United States, Mississippi

Practice Dr. David Headley

Port Gibson, Mississippi, United States, 39150

RECRUITING

United States, Missouri

HealthCare Research

Hazelwood, Missouri, United States, 63042

RECRUITING

United States, Nevada

Healor Primary Care/CCT Research

vegas, Nevada, United States, 89102

RECRUITING

United States, New York

Meridian Clinical Research, LLC

Vestal, New York, United States, 13850

RECRUITING

United States, North Carolina

Triad Clinical Trials

Greensboro, North Carolina, United States, 27410

RECRUITING

United States, Ohio

STAT Research

Vandalia, Ohio, United States, 45377

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Pennsylvania

Tristar Clinical Investigations, P.C.

Philadelphia, Pennsylvania, United States, 19114

RECRUITING

United States, South Carolina

Velocity Clinical Research Greenville

Greenville, South Carolina, United States, 29615

RECRUITING

United States, Texas

PCCR Solutions

Colleyville, Texas, United States, 76034

RECRUITING

United States, Texas

Pioneer Research Solutions, Inc.

Houston, Texas, United States, 77099

RECRUITING

United States, Texas

Southwest Rheumatology Research LLC

Mesquite, Texas, United States, 75150

RECRUITING

United States, Texas

Endeavor Clinical Trials

Saint Anthony, Texas, United States, 78240

RECRUITING

United States, Texas

DM Clinical Research

Tomball, Texas, United States, 77377

RECRUITING

United States, Utah

Highland Clinical Research

Salt Lake City, Utah, United States, 84124

RECRUITING

United States, Utah

South Ogden Family Medicine/CCT Research

South Ogden, Utah, United States, 84405

RECRUITING

United States, Utah

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States, 84088

RECRUITING

United States, Virginia

Meridian Clinical Research, LLC

Portsmouth, Virginia, United States, 23703

RECRUITING

United States, Virginia

Dominion Medical Associates, Inc.

Richmond, Virginia, United States, 23219

RECRUITING

United States, Virginia

Clinical Research Partners, LLC

Richmond, Virginia, United States, 23226