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Purpose

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 and 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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tigulixostat 100mg 		Tigulixostat 100mg, Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other names:
    • LC350189
Experimental
Tigulixostat 200mg 		Tigulixostat 200mg, Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other names:
    • LC350189
Experimental
Tigulixostat 300mg 		Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other names:
    • LC350189
Active Comparator
Titrated allopurinol (100-800mg) 		Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.
  • Drug: Allopurinol
    Xanthine Oxidase Inhibitor
Placebo Comparator
Placebo 		Placebo, three times a day (TID) for up to 6 months.
  • Drug: Placebo
    Matching placebo

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249

Alliance for Multispecialty Research, LLC
Daphne, Alabama 36526

Alliance for Multispecialty Research, LLC
Mobile, Alabama 36608

Syed Research Consultants, LLC
Muscle Shoals, Alabama 35661

Syed Research Consultants, LLC
Sheffield, Alabama 35660

Arizona Research Clinic, PLLC
Chandler, Arizona 85225

Arizona Arthritis & Rheumatology Associates, P.C.
Flagstaff, Arizona 86001

Arizona Arthritis and Rheumatology Research PLLC
Glendale, Arizona 85306

Arizon Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85210

Desert Clinical Research/CCT Research
Mesa, Arizona 85213

Elite Clinical Studies, LLC
Phoenix, Arizona 85018

Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona 85283

Lynn Institute of the Ozarks
Little Rock, Arkansas 72204

Velocity Clinical Research
Banning, California 92220

American Clinical Trials
Buena Park, California 90620

Shreenath Clinical Service
Lakewood, California 90805

Rancho Cucamonga Clinical Research
Rancho Cucamonga, California 91730

TriWest Research Associates
San Diego, California 92108

Rheumatology Center of San Diego
San Diego, California 92128

Arthritis & Rheumatic Disease Specialties
Aventura, Florida 33180

Clinical Research of West Florida, Inc.
Clearwater, Florida 33765

Herco Medical and Research Center, Inc
Coral Gables, Florida 33134

Nouvelle Clinical Research LLC
Cutler Bay, Florida 33189

Omega Research Debary, LLC
DeBary, Florida 32713

Alliance for Multispecialty Research, LLC
Fort Myers, Florida 33912

Direct Helpers Research Center
Hialeah, Florida 33012

Best Quality Research, Inc
Hialeah, Florida 33016

New Generation Of Medical Research, LLC
Hialeah, Florida 33016

Vital Pharma Research
Hialeah, Florida 33016

Accel Research Sites - Lakeland
Lake Mary, Florida 32746

Accel Research Sites - St. Petersburg- Largo
Lake Mary, Florida 32746

ARS-Matiland Clinical Research Unit
Lake Mary, Florida 32746

Homestead Associates in Research,Inc
Miami, Florida 33032

Allied Biomedical Research Institute
Miami, Florida 33155

D&H National Research Centers, Inc.
Miami, Florida 33155

Ivetmar Medical Group, LLC
Miami, Florida 33155

Care Research Center Inc
Miami, Florida 33175

Pharmax Research of South Florida, Inc
Miami, Florida 33175

Miami Dade Medical Research Institute, LLC
Miami, Florida 33176

Clinical Site Partners, LLC dba Flourish Research
Miami, Florida 33186

M&A Medical Centers and Research
Miami, Florida 33186

HMD Research LLC
Orlando, Florida 32819

IMA Clinical Research
Saint Petersburg, Florida 33709

Adult Medicine of Lake County, Inc.
Tampa, Florida 32757

Research Institute of South Florida, Inc.
Tampa, Florida 33173

Clinical Research of West Florida, Inc.
Tampa, Florida 33606

Clinical Research Trials of Florida, Inc.
Tampa, Florida 33607

Nodal Medical Center
Tampa, Florida 33607

ForCare Clinical Research
Tampa, Florida 33613

Clinical Site Partners LLC dba CSP Orlando
Winter Park, Florida 32789

Conquest Research
Winter Park, Florida 32789

Centricity Research
Columbus, Georgia 31904

Arthritis Center of North Georgia
Gainesville, Georgia 30501

Vista Clinical Research, LLC
Newnan, Georgia 30265

East West Medical Research Institute
Honolulu, Hawaii 96814

Family Care Research, LLC
Boise, Idaho 83713

Alliance for Multispecialty Research, LLC
Meridian, Idaho 83642

IMA Research, Inc.
Chicago, Illinois 60602

Great Lakes Clinical Trials
Chicago, Illinois 60640

Healthcare Research Network II, LLC
Flossmoor, Illinois 60422

Clinical Investigation Specialists, Inc
Gurnee, Illinois 60031

MediSphere Medical Research Center, LLC
Evansville, Indiana 47714

American Health Network of Indiana, LLC
Franklin, Indiana 46131

American Health Network of Indiana LLC
Muncie, Indiana 47304

Integrated Clinical Trial Services Inc.
West Des Moines, Iowa 50265

Women's & Family Care LLC, dba GTC Research
Shawnee Mission, Kansas 66218

Alliance for Multispecialty Research, LLC
Wichita, Kansas 67207

Alliance for Multispecialty Research, LLC
Lexington, Kentucky 40509

Omega Research Debary, LLC
Versailles, Kentucky 40383

Clinical Trials Management, LLC
Covington, Louisiana 70433

Clinical Trials Management
Metairie, Louisiana 70006

MD Medical Research
Oxon Hill, Maryland 20745

Elite Clinical Research, LLC
Jackson, Mississippi 39202

Olive Branch Family Medical Center
Olive Branch, Mississippi 38654

Practice Dr David Headley
Port Gibson, Mississippi 39150

Healthcare Research Network
Hazelwood, Missouri 63042

Alliance for Multispecialty Research, LLC
Kansas City, Missouri 64114

Clay-Platte Family Medicine Clinic
Kansas City, Missouri 64151

IMA Clinical Research
Saint Louis, Missouri 63117

St. Louis Medical Professionals, LLC
Saint Louis, Missouri 63119

Montana Medical Research, Inc.
Missoula, Montana 59808

Methodist Physicians Clinic/CCT Research
Fremont, Nebraska 68025

Meridian Clinical Research, LLC
Norfolk, Nebraska 68701

Healor Primary Care /CCT Research
Las Vegas, Nevada 89102

Wake Research - CRCN
Las Vegas, Nevada 89118

Alliance for Multispecialty Research, LLC.
Las Vegas, Nevada 89119

Albuquerque Center for Rheumatology
Albuquerque, New Mexico 87102

Inspire Santa Fe Medical Group
Santa Fe, New Mexico 87505

Long Island Regional Arthritis & Osteoporosis Care PC
Babylon, New York 11702

IMA Clinical Research
New York, New York 10036

Conquest Research
Vestal, New York 13850

Presbyterian Hospital
Charlotte, North Carolina 28277

Triad Clinical Trials, LLC
Greensboro, North Carolina 27410

Olympus Family Medicine
Hendersonville, North Carolina 28792

Burke Primary Care
Morganton, North Carolina 28655

Carolina Research Center, Inc.
Shelby, North Carolina 28150

Lillestol Research LLC
Fargo, North Dakota 58104

Trinity Health Center Medical Arts
Minot, North Dakota 58701

Arthritis Associates of Northwest Ohio Inc.
Perrysburg, Ohio 43551

STAT Research
Vandalia, Ohio 45377

Hatboro Medical Associates, P.C.
Hatboro, Pennsylvania 19040

Tristar Clinical Investigations, P.C.
Philadelphia, Pennsylvania 19114

New Phase Research
Knoxville, Tennessee 37909

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee 37920

Inquest Clinical Research
Baytown, Texas 77521

PCCR Solutions
Colleyville, Texas 76034

Metroplex Clinical Research Center
Dallas, Texas 75231

DFW Clinical Research
Dallas, Texas 75234

Dallas Fort Worth Clinical Research Associates
Fort Worth, Texas 76177

Pioneer Research Solutions, Inc.
Houston, Texas 77099

Southwest Rheumatology Research, LLC
Mesquite, Texas 75150

AIM Trials, LLC
Plano, Texas 75093

Clinical Trials of Texas, Inc.
San Antonio, Texas 78229

Sugar Lakes Family Practice, PA
Sugar Land, Texas 77479

DM Clinical Research
Tomball, Texas 77375

DM Clinical Research
Tomball, Texas 77377

Cope Family Medicine/CCT Research
Bountiful, Utah 84010

Olympus Family Medicine
Salt Lake City, Utah 84117

Highland Clinical Research
Salt Lake City, Utah 84124

South Ogden Family Medicine Clinic
South Ogden, Utah 84405

Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088

Meridian Clinical Research, LLC
Portsmouth, Virginia 23703

Dominion Medical Associates, Inc.
Richmond, Virginia 23219

Arthritis Northwest, PLLC
Spokane, Washington 99204

More Details

Status
Recruiting
Sponsor
LG Chem

Study Contact

Younghwan Jang
+82-2-6987-4154
younghj@lgchem.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.