Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
NCT ID: NCT05586958
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2022-10-25
2024-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tigulixostat 100mg
Tigulixostat 100mg, Once a day (QD) for up to 6 months
Tigulixostat
Xanthine Oxidase Inhibitor
Tigulixostat 200mg
Tigulixostat 200mg, Once a day (QD) for up to 6 months
Tigulixostat
Xanthine Oxidase Inhibitor
Tigulixostat 300mg
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months
Tigulixostat
Xanthine Oxidase Inhibitor
Placebo
Placebo, Once a day (QD) for up to 6 months
Placebo
Matching placebo
Interventions
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Tigulixostat
Xanthine Oxidase Inhibitor
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Principal Investigators
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Hyungjin Cho, MD
Role: STUDY_DIRECTOR
LG Chem
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Medvin Clinical Research
Covina, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Research Institute of South Florida, Inc.
Miami, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Conquest Research, LLC
Winter Park, Florida, United States
Vista Clinical Research, LLC
Newnan, Georgia, United States
Velocity Clinical Research
Meridian, Idaho, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
MD Medical Research
Oxon Hill, Maryland, United States
Elite Clinical Research, LLC
Jackson, Mississippi, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Practice Dr. David Headley
Port Gibson, Mississippi, United States
HealthCare Research
Hazelwood, Missouri, United States
Healor Primary Care/CCT Research
Las Vegas, Nevada, United States
Meridian Clinical Research, LLC
Vestal, New York, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
STAT Research
Vandalia, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Tristar Clinical Investigations, P.C.
Philadelphia, Pennsylvania, United States
Velocity Clinical Research Greenville
Greenville, South Carolina, United States
PCCR Solutions
Colleyville, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Highland Clinical Research
Salt Lake City, Utah, United States
South Ogden Family Medicine/CCT Research
South Ogden, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
LTD "Clinic LJ"
Kutaisi, , Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi, , Georgia
LTD Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
JSC "Vian"
Tbilisi, , Georgia
LTD MediClub Georgia
Tbilisi, , Georgia
LTD Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
Angeles University Foundation Medical Center
Angeles, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Lipa Medix Medical Center
Lipa, , Philippines
Makati Medical Center
Makati, , Philippines
Manila Doctors Hospital
Manila, , Philippines
ManilaMed - Medical Center
Manila, , Philippines
Phramongkutklao Hospital
Bangkok, , Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Siriraj Hospital
Bangkoknoi, , Thailand
Thammasat University Hospital
Khlong Luang, , Thailand
Countries
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References
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Saag KG, Dalbeth N, Hsu CY, Kuo CF, Nuki G, Perez-Ruiz F, White WB, Hariri A, Lee Y, Jang Y, Han S, Choi HK. Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies. Contemp Clin Trials. 2025 Apr;151:107843. doi: 10.1016/j.cct.2025.107843. Epub 2025 Feb 8.
Other Identifiers
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LG-GDCL009
Identifier Type: -
Identifier Source: org_study_id