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NCT05586971 Clinical Trial

Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

Gout Clinical Trial

— EURELIA2  

Official title:
A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05586971
Other study ID # LG-GDCL010
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 30, 2023
Est. completion date December 2025

Study information
Verified date October 2023
Source LG Chem
Contact Younghwan Jang
Phone +82-2-6987-4154
Email younghj@lgchem.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2542
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tigulixostat
Xanthine Oxidase Inhibitor
• Allopurinol
Xanthine Oxidase Inhibitor
• Placebo
Matching placebo

Locations
Country Name City State
United States Albuquerque Center for Rheumatology Albuquerque New Mexico
United States Arthritis & Rheumatic Disease Specialties Aventura Florida
United States Long Island Regional Arthritis & Osteoporosis Care PC Babylon New York
United States Velocity Clinical Research Banning California
United States Inquest Clinical Research Baytown Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Family Care Research, LLC Boise Idaho
United States Cope Family Medicine/CCT Research Bountiful Utah
United States American Clinical Trials Buena Park California
United States Arizona Research Clinic, PLLC Chandler Arizona
United States Presbyterian Hospital Charlotte North Carolina
United States Great Lakes Clinical Trials Chicago Illinois
United States IMA Research, Inc. Chicago Illinois
United States Clinical Research of West Florida, Inc. Clearwater Florida
United States PCCR Solutions Colleyville Texas
United States Centricity Research Columbus Georgia
United States Herco Medical and Research Center, Inc Coral Gables Florida
United States Clinical Trials Management, LLC Covington Louisiana
United States Nouvelle Clinical Research LLC Cutler Bay Florida
United States DFW Clinical Research Dallas Texas
United States Metroplex Clinical Research Center Dallas Texas
United States Alliance for Multispecialty Research, LLC Daphne Alabama
United States Omega Research Debary, LLC DeBary Florida
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States Lillestol Research LLC Fargo North Dakota
United States Arizona Arthritis & Rheumatology Associates, P.C. Flagstaff Arizona
United States Healthcare Research Network II, LLC Flossmoor Illinois
United States Alliance for Multispecialty Research, LLC Fort Myers Florida
United States Dallas Fort Worth Clinical Research Associates Fort Worth Texas
United States American Health Network of Indiana, LLC Franklin Indiana
United States Methodist Physicians Clinic/CCT Research Fremont Nebraska
United States Arthritis Center of North Georgia Gainesville Georgia
United States Arizona Arthritis and Rheumatology Research PLLC Glendale Arizona
United States Triad Clinical Trials, LLC Greensboro North Carolina
United States Clinical Investigation Specialists, Inc Gurnee Illinois
United States Hatboro Medical Associates, P.C. Hatboro Pennsylvania
United States Healthcare Research Network Hazelwood Missouri
United States Olympus Family Medicine Hendersonville North Carolina
United States Best Quality Research, Inc Hialeah Florida
United States Direct Helpers Research Center Hialeah Florida
United States New Generation Of Medical Research, LLC Hialeah Florida
United States Vital Pharma Research Hialeah Florida
United States East West Medical Research Institute Honolulu Hawaii
United States Pioneer Research Solutions, Inc. Houston Texas
United States Elite Clinical Research, LLC Jackson Mississippi
United States Alliance for Multispecialty Research, LLC Kansas City Missouri
United States Clay-Platte Family Medicine Clinic Kansas City Missouri
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States New Phase Research Knoxville Tennessee
United States Accel Research Sites - Lakeland Lake Mary Florida
United States Accel Research Sites - St. Petersburg- Largo Lake Mary Florida
United States ARS-Matiland Clinical Research Unit Lake Mary Florida
United States Shreenath Clinical Service Lakewood California
United States Alliance for Multispecialty Research, LLC. Las Vegas Nevada
United States Healor Primary Care /CCT Research Las Vegas Nevada
United States Wake Research - CRCN Las Vegas Nevada
United States Alliance for Multispecialty Research, LLC Lexington Kentucky
United States Lynn Institute of the Ozarks Little Rock Arkansas
United States Alliance for Multispecialty Research, LLC Meridian Idaho
United States Arizon Arthritis & Rheumatology Research, PLLC Mesa Arizona
United States Desert Clinical Research/CCT Research Mesa Arizona
United States Southwest Rheumatology Research, LLC Mesquite Texas
United States Clinical Trials Management Metairie Louisiana
United States Allied Biomedical Research Institute Miami Florida
United States Care Research Center Inc Miami Florida
United States Clinical Site Partners, LLC dba Flourish Research Miami Florida
United States D&H National Research Centers, Inc. Miami Florida
United States Homestead Associates in Research,Inc Miami Florida
United States Ivetmar Medical Group, LLC Miami Florida
United States M&A Medical Centers and Research Miami Florida
United States Miami Dade Medical Research Institute, LLC Miami Florida
United States Pharmax Research of South Florida, Inc Miami Florida
United States Trinity Health Center Medical Arts Minot North Dakota
United States Montana Medical Research, Inc. Missoula Montana
United States Alliance for Multispecialty Research, LLC Mobile Alabama
United States Burke Primary Care Morganton North Carolina
United States American Health Network of Indiana LLC Muncie Indiana
United States Syed Research Consultants, LLC Muscle Shoals Alabama
United States IMA Clinical Research New York New York
United States Vista Clinical Research, LLC Newnan Georgia
United States Meridian Clinical Research, LLC Norfolk Nebraska
United States Olive Branch Family Medical Center Olive Branch Mississippi
United States HMD Research LLC Orlando Florida
United States MD Medical Research Oxon Hill Maryland
United States Arthritis Associates of Northwest Ohio Inc. Perrysburg Ohio
United States Tristar Clinical Investigations, P.C. Philadelphia Pennsylvania
United States Elite Clinical Studies, LLC Phoenix Arizona
United States AIM Trials, LLC Plano Texas
United States Practice Dr David Headley Port Gibson Mississippi
United States Meridian Clinical Research, LLC Portsmouth Virginia
United States Rancho Cucamonga Clinical Research Rancho Cucamonga California
United States Dominion Medical Associates, Inc. Richmond Virginia
United States IMA Clinical Research Saint Louis Missouri
United States St. Louis Medical Professionals, LLC Saint Louis Missouri
United States IMA Clinical Research Saint Petersburg Florida
United States Highland Clinical Research Salt Lake City Utah
United States Olympus Family Medicine Salt Lake City Utah
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Rheumatology Center of San Diego San Diego California
United States TriWest Research Associates San Diego California
United States Inspire Santa Fe Medical Group Santa Fe New Mexico
United States Women's & Family Care LLC, dba GTC Research Shawnee Mission Kansas
United States Syed Research Consultants, LLC Sheffield Alabama
United States Carolina Research Center, Inc. Shelby North Carolina
United States South Ogden Family Medicine Clinic South Ogden Utah
United States Arthritis Northwest, PLLC Spokane Washington
United States Sugar Lakes Family Practice, PA Sugar Land Texas
United States Adult Medicine of Lake County, Inc. Tampa Florida
United States Clinical Research of West Florida, Inc. Tampa Florida
United States Clinical Research Trials of Florida, Inc. Tampa Florida
United States ForCare Clinical Research Tampa Florida
United States Nodal Medical Center Tampa Florida
United States Research Institute of South Florida, Inc. Tampa Florida
United States Fiel Family and Sports Medicine/CCT Research Tempe Arizona
United States DM Clinical Research Tomball Texas
United States DM Clinical Research Tomball Texas
United States STAT Research Vandalia Ohio
United States Omega Research Debary, LLC Versailles Kentucky
United States Conquest Research Vestal New York
United States Integrated Clinical Trial Services Inc. West Des Moines Iowa
United States Velocity Clinical Research, Salt Lake City West Jordan Utah
United States Alliance for Multispecialty Research, LLC Wichita Kansas
United States Clinical Site Partners LLC dba CSP Orlando Winter Park Florida
United States Conquest Research Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 Serum uric acid (sUA) level will be measured at Month 4,5, and 6 Up to Month 6
Secondary The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6 Serum uric acid (sUA) level will be measured at Month 4,5, and 6 Up to Month 6
Secondary Proportion of subjects with at least one gout flare from Month 6 to Month 12. Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months From Month 6 to Month 12
Secondary Proportion of subjects with complete resolution of =1 target tophus by Month 12 Tophi will be measured by independent central blind reader Up to Month 12
Secondary Incidence rate of adverse event Safety assessment Up to Month 12
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