CompletedPhase 3
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Key facts
- Where
- Albuquerque, Aventura, Babylon, Banning, Baytown, Birmingham, Boise, Bountiful, Buena Park, Chandler, Charlotte, Chicago, Clearwater, Colleyville, Columbus, Coral Gables, Covington, Cutler Bay, Dallas, Daphne, DeBary, Evansville, Fargo, Flagstaff, Flossmoor, Fort Myers, Fort Worth, Franklin, Fremont, Gainesville, Glendale, Greensboro, Gurnee, Hatboro, Hazelwood, Hendersonville, Hialeah, Honolulu, Houston, Jackson, Kansas City, Knoxville, Lake Mary, Lakewood, Las Vegas, Lexington, Little Rock, Meridian, Mesa, Mesquite, Metairie, Miami, Minot, Missoula, Mobile, Morganton, Muncie, Muscle Shoals, New York, Newnan, Norfolk, Olive Branch, Orlando, Oxon Hill, Perrysburg, Philadelphia, Phoenix, Plano, Port Gibson, Portsmouth, Rancho Cucamonga, Richmond, Salt Lake City, San Antonio, San Diego, Santa Fe, Shawnee Mission, Sheffield, Shelby, South Ogden, Spokane, St Louis, St. Petersburg, Sugar Land, Tampa, Tempe, Tomball, Vandalia, Versailles, Vestal, West Des Moines, West Jordan, Wichita, and Winter Park, United StatesSee the 123 sites
- Phase
- Phase 3
Where in United States
- Albuquerque Center for RheumatologyAlbuquerque, United StatesNo longer taking part
- Arthritis & Rheumatic Disease SpecialtiesAventura, United StatesNo longer taking part
- Long Island Regional Arthritis & Osteoporosis Care PCBabylon, United StatesNo longer taking part
- Velocity Clinical ResearchBanning, United StatesNo longer taking part
- Inquest Clinical ResearchBaytown, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Family Care Research, LLCBoise, United StatesNo longer taking part
- Cope Family Medicine/CCT ResearchBountiful, United StatesNo longer taking part
- American Clinical TrialsBuena Park, United StatesNo longer taking part
- Arizona Research Clinic PLLCChandler, United StatesNo longer taking part
- Presbyterian HospitalCharlotte, United StatesNo longer taking part
- Great Lakes Clinical TrialsChicago, United StatesNo longer taking part
- IMA Research, Inc.Chicago, United StatesNo longer taking part
- Clinical Research of West Florida, Inc.Clearwater, United StatesNo longer taking part
- PCCR SolutionsColleyville, United StatesNo longer taking part
- Centricity ResearchColumbus, United StatesNo longer taking part
- Herco Medical and Research Center, IncCoral Gables, United StatesNo longer taking part
- Clinical Trials Management, LLCCovington, United StatesNo longer taking part
- Nouvelle Clinical Research LLCCutler Bay, United StatesNo longer taking part
- DFW Clinical ResearchDallas, United StatesNo longer taking part
- Metroplex Clinical Research CenterDallas, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCDaphne, United StatesNo longer taking part
- Omega Research Debary, LLCDeBary, United StatesNo longer taking part
- MediSphere Medical Research Center, LLCEvansville, United StatesNo longer taking part
- Lillestol Research, LLCFargo, United StatesNo longer taking part
- Arizona Arthritis & Rheumatology Associates P.C.Flagstaff, United StatesNo longer taking part
- Healthcare Research Network II, LLCFlossmoor, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCFort Myers, United StatesNo longer taking part
- Dallas Fort Worth Clinical Research AssociatesFort Worth, United StatesNo longer taking part
- American Health Network of Indiana, LLCFranklin, United StatesNo longer taking part
- Methodist Physicians Clinic / CCT ResearchFremont, United StatesNo longer taking part
- Arthritis Center of North GeorgiaGainesville, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology Research PLLCGlendale, United StatesNo longer taking part
- Triad Clinical Trials, LLCGreensboro, United StatesNo longer taking part
- Clinical Investigation Specialists, Inc.Gurnee, United StatesNo longer taking part
- Hatboro Medical Associates, P.C.Hatboro, United StatesNo longer taking part
- Healthcare Research NetworkHazelwood, United StatesNo longer taking part
- Olympus Family MedicineHendersonville, United StatesNo longer taking part
- Best Quality Research, IncHialeah, United StatesNo longer taking part
- Direct Helpers Research CenterHialeah, United StatesNo longer taking part
- New Generation of Medical Research, LLC.Hialeah, United StatesNo longer taking part
- Vital Pharma ResearchHialeah, United StatesNo longer taking part
- East-West Medical Research InstituteHonolulu, United StatesNo longer taking part
- Pioneer Research Solutions, Inc.Houston, United StatesNo longer taking part
- Elite Clinical Research LLCJackson, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCKansas City, United StatesNo longer taking part
- Clay-Platte Family Medicine ClinicKansas City, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCKnoxville, United StatesNo longer taking part
- New Phase ResearchKnoxville, United StatesNo longer taking part
- Accel Research Sites - LakelandLake Mary, United StatesNo longer taking part
- Accel Research Sites - St. Petersburg- LargoLake Mary, United StatesNo longer taking part
- ARS-Matiland Clinical Research UnitLake Mary, United StatesNo longer taking part
- Shreenath Clinical ServiceLakewood, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCLas Vegas, United StatesNo longer taking part
- Healor Primary Care / CCT ResearchLas Vegas, United StatesNo longer taking part
- Wake Research - CRCNLas Vegas, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCLexington, United StatesNo longer taking part
- Lynn Institute of the OzarksLittle Rock, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCMeridian, United StatesNo longer taking part
- Arizon Arthritis & Rheumatology Research, PLLCMesa, United StatesNo longer taking part
- Desert Clinical Research/CCT ResearchMesa, United StatesNo longer taking part
- SouthWest Rheumatology Research, LLCMesquite, United StatesNo longer taking part
- Clinical Trials ManagementMetairie, United StatesNo longer taking part
- Allied Biomedical Research InstituteMiami, United StatesNo longer taking part
- Care Research Center IncMiami, United StatesNo longer taking part
- Clinical Site Partners LLC, dba Flourish ResearchMiami, United StatesNo longer taking part
- D&H National Research Centers, IncMiami, United StatesNo longer taking part
- Homestead Associates in Research Inc.Miami, United StatesNo longer taking part
- Ivetmar Medical Group, LLCMiami, United StatesNo longer taking part
- M&A Medical Centers and ResearchMiami, United StatesNo longer taking part
- Miami Dade Medical Research Institute, LLCMiami, United StatesNo longer taking part
- Pharmax Research of South Florida, IncMiami, United StatesNo longer taking part
- Trinity Health Center Medical ArtsMinot, United StatesNo longer taking part
- Montana Medical Research, IncMissoula, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCMobile, United StatesNo longer taking part
- Burke Primary CareMorganton, United StatesNo longer taking part
- American Health Network of Indiana LLCMuncie, United StatesNo longer taking part
- Syed Research Consultants, LLCMuscle Shoals, United StatesNo longer taking part
- IMA Clinical ResearchNew York, United StatesNo longer taking part
- Vista Clinical Research, LLCNewnan, United StatesNo longer taking part
- Meridian Clinical Research, LLCNorfolk, United StatesNo longer taking part
- Olive Branch Family Medical CenterOlive Branch, United StatesNo longer taking part
- HMD Research, LLCOrlando, United StatesNo longer taking part
- MD Medical ResearchOxon Hill, United StatesNo longer taking part
- Arthritis Associates of Northwest Ohio Inc.Perrysburg, United StatesNo longer taking part
- Tristar Clinical Investigations, P.C.Philadelphia, United StatesNo longer taking part
- Elite Clinical Studies, LLCPhoenix, United StatesNo longer taking part
- Aim Trials, LLCPlano, United StatesNo longer taking part
- Practice Dr. David HeadleyPort Gibson, United StatesNo longer taking part
- Meridian Clinical Research, LLCPortsmouth, United StatesNo longer taking part
- Rancho Cucamonga Clinical ResearchRancho Cucamonga, United StatesNo longer taking part
- Dominion Medical Associates, Inc.Richmond, United StatesNo longer taking part
- Highland Clinical ResearchSalt Lake City, United StatesNo longer taking part
- Olympus Family MedicineSalt Lake City, United StatesNo longer taking part
- Clinical Trials of Texas IncSan Antonio, United StatesNo longer taking part
- Rheumatology Center of San DiegoSan Diego, United StatesNo longer taking part
- Triwest Research AssociatesSan Diego, United StatesNo longer taking part
- Inspire Santa Fe Medical GroupSanta Fe, United StatesNo longer taking part
- Women's & Family Care LLC, dba GTC ResearchShawnee Mission, United StatesNo longer taking part
- Syed Research Consultants LlcSheffield, United StatesNo longer taking part
- Carolina Research Center, IncShelby, United StatesNo longer taking part
- South Ogden Family Medicine ClinicSouth Ogden, United StatesNo longer taking part
- Arthritis Northwest, PLLCSpokane, United StatesNo longer taking part
- IMA Clinical ResearchSt Louis, United StatesNo longer taking part
- St. Louis Medical Professionals, LLCSt Louis, United StatesNo longer taking part
- IMA Clinical ResearchSt. Petersburg, United StatesNo longer taking part
- Sugar Lakes Family Practice, PASugar Land, United StatesNo longer taking part
- Adult Medicine of Lake County, Inc.Tampa, United StatesNo longer taking part
- Clinical Research of West Florida IncTampa, United StatesNo longer taking part
- Clinical Research Trials of Florida, Inc.Tampa, United StatesNo longer taking part
- ForCare Clinical ResearchTampa, United StatesNo longer taking part
- Nodal Medical CenterTampa, United StatesNo longer taking part
- Research Institute of South Florida, Inc.Tampa, United StatesNo longer taking part
- Fiel Family and Sports Medicine/CCT ResearchTempe, United StatesNo longer taking part
- DM Clinical ResearchTomball, United StatesNo longer taking part
- STAT ResearchVandalia, United StatesNo longer taking part
- Versailles Family MedicineVersailles, United StatesNo longer taking part
- Conquest ResearchVestal, United StatesNo longer taking part
- Integrated Clinical Trial Services, Inc.West Des Moines, United StatesNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesNo longer taking part
- Alliance for Multispecialty Research LLCWichita, United StatesNo longer taking part
- Clinical Site Partners, LLC DBA CSP OrlandoWinter Park, United StatesNo longer taking part
- Conquest ResearchWinter Park, United StatesNo longer taking part
Trial details
- Who runs it
- LG Chem
- Trial code
- NCT05586971EU 2022-501421-20-00
- Record updated
- 22 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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); Subjects with secondary hyperuricemia and enzymatic defects.