| Condition or Disease | Intervention/Treatment |
|---|---|
GoutHyperuricemiaGout FlareTophi | Drug: TigulixostatDrug: TigulixostatDrug: TigulixostatDrug: AllopurinolDrug: Placebo |
ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
GoutHyperuricemiaGout FlareTophi | Drug: TigulixostatDrug: TigulixostatDrug: TigulixostatDrug: AllopurinolDrug: Placebo |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 2202 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | March 29, 2023 |
| Actual Primary Completion Date | May 5, 2025 |
| Actual Study Completion Date | May 5, 2025 |
| Group/Cohort | Intervention/Treatment |
|---|---|
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| Ages Eligible for Study | (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | 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). |
| Sponsors and Collaborators | LG Chem |
|---|---|
| Locations | University of Alabama at Birmingham | Birmingham Alabama, United States, 35249Alliance for Multispecialty Research, LLC | Daphne Alabama, United States, 36526Alliance for Multispecialty Research, LLC | Mobile Alabama, United States, 36608Syed Research Consultants, LLC | Muscle Shoals Alabama, United States, 35661Syed Research Consultants, LLC | Sheffield Alabama, United States, 35660Arizona Research Clinic, PLLC | Chandler Arizona, United States, 85225Arizona Arthritis & Rheumatology Associates, P.C. | Flagstaff Arizona, United States, 86001Arizona Arthritis and Rheumatology Research PLLC | Glendale Arizona, United States, 85306Arizon Arthritis & Rheumatology Research, PLLC | Mesa Arizona, United States, 85210Desert Clinical Research/CCT Research | Mesa Arizona, United States, 85213Elite Clinical Studies, LLC | Phoenix Arizona, United States, 85018Fiel Family and Sports Medicine/CCT Research | Tempe Arizona, United States, 85283Lynn Institute of the Ozarks | Little Rock Arkansas, United States, 72204Velocity Clinical Research | Banning California, United States, 92220American Clinical Trials | Buena Park California, United States, 90620Shreenath Clinical Service | Lakewood California, United States, 90805Rancho Cucamonga Clinical Research | Rancho Cucamonga California, United States, 91730TriWest Research Associates | San Diego California, United States, 92108Rheumatology Center of San Diego | San Diego California, United States, 92128Arthritis & Rheumatic Disease Specialties | Aventura Florida, United States, 33180Clinical Research of West Florida, Inc. | Clearwater Florida, United States, 33765Herco Medical and Research Center, Inc | Coral Gables Florida, United States, 33134Nouvelle Clinical Research LLC | Cutler Bay Florida, United States, 33189Omega Research Debary, LLC | DeBary Florida, United States, 32713Alliance for Multispecialty Research, LLC | Fort Myers Florida, United States, 33912Direct Helpers Research Center | Hialeah Florida, United States, 33012Best Quality Research, Inc | Hialeah Florida, United States, 33016New Generation Of Medical Research, LLC | Hialeah Florida, United States, 33016Vital Pharma Research | Hialeah Florida, United States, 33016Accel Research Sites - Lakeland | Lake Mary Florida, United States, 32746Accel Research Sites - St. Petersburg- Largo | Lake Mary Florida, United States, 32746ARS-Matiland Clinical Research Unit | Lake Mary Florida, United States, 32746Homestead Associates in Research,Inc | Miami Florida, United States, 33032Allied Biomedical Research Institute | Miami Florida, United States, 33155D&H National Research Centers, Inc. | Miami Florida, United States, 33155Ivetmar Medical Group, LLC | Miami Florida, United States, 33155Care Research Center Inc | Miami Florida, United States, 33175Pharmax Research of South Florida, Inc | Miami Florida, United States, 33175Miami Dade Medical Research Institute, LLC | Miami Florida, United States, 33176Clinical Site Partners, LLC dba Flourish Research | Miami Florida, United States, 33186M&A Medical Centers and Research | Miami Florida, United States, 33186HMD Research LLC | Orlando Florida, United States, 32819IMA Clinical Research | St. Petersburg Florida, United States, 33709Adult Medicine of Lake County, Inc. | Tampa Florida, United States, 32757Research Institute of South Florida, Inc. | Tampa Florida, United States, 33173Clinical Research of West Florida, Inc. | Tampa Florida, United States, 33606Clinical Research Trials of Florida, Inc. | Tampa Florida, United States, 33607Nodal Medical Center | Tampa Florida, United States, 33607ForCare Clinical Research | Tampa Florida, United States, 33613Clinical Site Partners LLC dba CSP Orlando | Winter Park Florida, United States, 32789Conquest Research | Winter Park Florida, United States, 32789Centricity Research | Columbus Georgia, United States, 31904Arthritis Center of North Georgia | Gainesville Georgia, United States, 30501Vista Clinical Research, LLC | Newnan Georgia, United States, 30265East West Medical Research Institute | Honolulu Hawaii, United States, 96814Family Care Research, LLC | Boise Idaho, United States, 83713Alliance for Multispecialty Research, LLC | Meridian Idaho, United States, 83642IMA Research, Inc. | Chicago Illinois, United States, 60602Great Lakes Clinical Trials | Chicago Illinois, United States, 60640Healthcare Research Network II, LLC | Flossmoor Illinois, United States, 60422Clinical Investigation Specialists, Inc | Gurnee Illinois, United States, 60031MediSphere Medical Research Center, LLC | Evansville Indiana, United States, 47714American Health Network of Indiana, LLC | Franklin Indiana, United States, 46131American Health Network of Indiana LLC | Muncie Indiana, United States, 47304Integrated Clinical Trial Services Inc. | West Des Moines Iowa, United States, 50265Women's & Family Care LLC, dba GTC Research | Shawnee Mission Kansas, United States, 66218Alliance for Multispecialty Research, LLC | Wichita Kansas, United States, 67207Alliance for Multispecialty Research, LLC | Lexington Kentucky, United States, 40509Versailles Family Medicine | Versailles Kentucky, United States, 40383Clinical Trials Management, LLC | Covington Louisiana, United States, 70433Clinical Trials Management | Metairie Louisiana, United States, 70006MD Medical Research | Oxon Hill Maryland, United States, 20745Elite Clinical Research, LLC | Jackson Mississippi, United States, 39202Olive Branch Family Medical Center | Olive Branch Mississippi, United States, 38654Practice Dr David Headley | Port Gibson Mississippi, United States, 39150Healthcare Research Network | Hazelwood Missouri, United States, 63042Alliance for Multispecialty Research, LLC | Kansas City Missouri, United States, 64114Clay-Platte Family Medicine Clinic | Kansas City Missouri, United States, 64151IMA Clinical Research | St Louis Missouri, United States, 63117St. Louis Medical Professionals, LLC | St Louis Missouri, United States, 63119Montana Medical Research, Inc. | Missoula Montana, United States, 59808Methodist Physicians Clinic/CCT Research | Fremont Nebraska, United States, 68025Meridian Clinical Research, LLC | Norfolk Nebraska, United States, 68701Healor Primary Care /CCT Research | Las Vegas Nevada, United States, 89102Wake Research - CRCN | Las Vegas Nevada, United States, 89118Alliance for Multispecialty Research, LLC. | Las Vegas Nevada, United States, 89119Albuquerque Center for Rheumatology | Albuquerque New Mexico, United States, 87102Inspire Santa Fe Medical Group | Santa Fe New Mexico, United States, 87505Long Island Regional Arthritis & Osteoporosis Care PC | Babylon New York, United States, 11702IMA Clinical Research | New York New York, United States, 10036Conquest Research | Vestal New York, United States, 13850Presbyterian Hospital | Charlotte North Carolina, United States, 28277Triad Clinical Trials, LLC | Greensboro North Carolina, United States, 27410Olympus Family Medicine | Hendersonville North Carolina, United States, 28792Burke Primary Care | Morganton North Carolina, United States, 28655Carolina Research Center, Inc. | Shelby North Carolina, United States, 28150Lillestol Research LLC | Fargo North Dakota, United States, 58104Trinity Health Center Medical Arts | Minot North Dakota, United States, 58701Arthritis Associates of Northwest Ohio Inc. | Perrysburg Ohio, United States, 43551STAT Research | Vandalia Ohio, United States, 45377Hatboro Medical Associates, P.C. | Hatboro Pennsylvania, United States, 19040Tristar Clinical Investigations, P.C. | Philadelphia Pennsylvania, United States, 19114New Phase Research | Knoxville Tennessee, United States, 37909Alliance for Multispecialty Research, LLC | Knoxville Tennessee, United States, 37920Inquest Clinical Research | Baytown Texas, United States, 77521PCCR Solutions | Colleyville Texas, United States, 76034Metroplex Clinical Research Center | Dallas Texas, United States, 75231DFW Clinical Research | Dallas Texas, United States, 75234Dallas Fort Worth Clinical Research Associates | Fort Worth Texas, United States, 76177Pioneer Research Solutions, Inc. | Houston Texas, United States, 77099Southwest Rheumatology Research, LLC | Mesquite Texas, United States, 75150AIM Trials, LLC | Plano Texas, United States, 75093Clinical Trials of Texas, Inc. | San Antonio Texas, United States, 78229Sugar Lakes Family Practice, PA | Sugar Land Texas, United States, 77479DM Clinical Research | Tomball Texas, United States, 77375DM Clinical Research | Tomball Texas, United States, 77377Cope Family Medicine/CCT Research | Bountiful Utah, United States, 84010Olympus Family Medicine | Salt Lake City Utah, United States, 84117Highland Clinical Research | Salt Lake City Utah, United States, 84124South Ogden Family Medicine Clinic | South Ogden Utah, United States, 84405Velocity Clinical Research, Salt Lake City | West Jordan Utah, United States, 84088Meridian Clinical Research, LLC | Portsmouth Virginia, United States, 23703Dominion Medical Associates, Inc. | Richmond Virginia, United States, 23219Arthritis Northwest, PLLC | Spokane Washington, United States, 99204Hospital Universitario Austral | Buenos Aires , Argentina, B1635Instituto de Investigaciones Clinicas San Nicolás | Buenos Aires , Argentina, B2900Centro Médico Reumatologico - Organizacion Medica de Investigacion S.A. (OMI) | Buenos Aires , Argentina, C1015Aprillus Asistencia e Investigacion Clinica | Buenos Aires , Argentina, C1406ACentro Privado de Medicina Familiar | Buenos Aires , Argentina, C1417EYGClinica Adventista Belgrano | Buenos Aires , Argentina, C1430EGFInstituto de Investigaciones Clinicas Cordoba | Córdoba , Argentina, X5000AAWCentro Integral De Dianogostico por Imagenes Marchegiani (CIDIM) | Córdoba , Argentina, X5000AVEInstituto Reumatologico Strusberg | Córdoba , Argentina, X5000EOCClinica Privada Velez Sarsfield (CPVS) | Córdoba , Argentina, X5016LIGCentro de Investigaciones Médicas Tucuman | San Miguel de Tucumán , Argentina, T4000Instituto CAICI (Instituto Centralizado de Asistencia e Investigacion Clinica Integral) | Santa Fe , Argentina, S2000PBJEmeritus Research (Melbourne) | Camberwell , Australia, 3124Holdsworth House Medical Practice | Darlinghurst , Australia, 2010Griffith University Clinical Trial Unit | Southport , Australia, 4111Emeritus Research (Sydney) | Sydney , Australia, 2019The Queen Elizabeth Hospital | Woodville South , Australia, 5011ReumaClinic | Genk , Belgium, 3600CHU de Liège | Liège , Belgium, 4000CHU HELORA - Hôpital de Mons - Site Kenedy | Mons , Belgium, 7000Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte , Brazil, 30150-221CETI - Centro de Estudos em Terapias Inovadoras | Curitiba , Brazil, 80030-110EDUMED - Educação em Saúde S/S Ltda | Curitiba , Brazil, 80440-080LMK Serviços Médicos Sociedade Simples | Curitiba , Brazil, 90480-000CMIP-Centro Mineiro de Pesquisa | Juiz de Fora , Brazil, 36010-570Hospital de Clínicas de Porto Alegre | Porto Alegre , Brazil, 90035-903SER - Serviços Especializados em Reumatologia da Bahia | Salvador , Brazil, 40150-150Clinica Medica Bonfiflioli Ltda | São Paulo , Brazil, 13015-001University Multiprofile Hospital for Active Treatment Plovdiv "Eurohospital" Ltd | Plovdiv , Bulgaria, 4004Mbal Lyulin EAD | Sofia , Bulgaria, 1336Medical Center Excelsior OOD | Sofia , Bulgaria, 1407DCC Fokus-5 Lzip OOD | Sofia , Bulgaria, 1463Medical Center-N.I. Pirogov EOOD | Sofia , Bulgaria, 1606Military medical academy | Sofia , Bulgaria, 1606Acibadem City Clinic Diagnostic And Consultation Center Ltd | Sofia , Bulgaria, 1784Medical Center Synexus Sofia EOOD | Sofia , Bulgaria, 1784Centro de Investigacion en Reumatología y Especialidades Médicas S.A.S (CIREEM S.A.S) | Bogotá , Colombia, 110221Servimed S.A.S. | Bucaramanga , Colombia, 680003IPS Medicos Internistas de Caldas SAS | Manizales , Colombia, 170004Healthy Medical Center SAS | Zipaquirá , Colombia, 250252MUDr. Michaela Blahova, revmatologicka ambulance s.r.o. | Brno , Czechia, 602 00REVMACLINIC s.r.o. | Brno , Czechia, 611 41L.K.N Arthrocentrum | Hlučín , Czechia, 748 01Revmatologicky ustav | New Town , Czechia, 128 50MEDICAL PLUS s.r.o. | Uherské Hradiště , Czechia, 686 01CHU De Bordeaux | Bordeaux , France, 33076Hôpital Saint Philibert | Lomme , France, 59160Hôpital Edourad Herriot | Lyon , France, 69003Hôpital Lapeyronie | Montpellier , France, 34295Centre Hospitalier Regional D'Orleans | Orléans , France, 45067CHU Hôpitaux De Rouen | Rouen , France, 76031"LJ Clinic" LTD | Kutaisi , Georgia, 4600Aleksandre Aladashvili Clinic LLC | Tbilisi , Georgia, 0102LTD "Israeli-Georgian Medical Research Clinic Helsicore" | Tbilisi , Georgia, 0112Cardioclinic - Digomi Medical Center | Tbilisi , Georgia, 0159JSC "Evex Hospitals" | Tbilisi , Georgia, 0159Tbilisi Heart and Vascular Clinic | Tbilisi , Georgia, 0159LTD MediClub Georgia | Tbilisi , Georgia, 0160Multiprofile Clinic Consilium Medula LTD | Tbilisi , Georgia, 0186Emovis GmbH | Berlin , Germany, 10629Gemeinschaftspraxis Dres. T. und N. Jung | Deggingen , Germany, 73326Klinische Forschung Dresden GmbH | Dresden , Germany, 01069Medizentrum Essen Borbeck | Essen , Germany, 45355Velocity Clincial Research Hamburg GmbH | Hamburg , Germany, 22143Praxis für klinische Studien | Hamburg , Germany, 22415Klinische Forschung Karlsruhe GmbH | Karlsruhe , Germany, 76137Klinische Forschung Schwerin GmbH | Schwerin , Germany, 19055Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria | Alessandria , Italy, 15121IRCCS Ospedale Galeazzi-Sant'Ambrogio | Milan , Italy, 20157AOU Policlinico Paolo Giaccone | Palermo , Italy, 90127AUSL di Reggio Emilia, Arcispedale Santa Maria Nuova-IRCCS | Reggio Emilia , Italy, 42123Azienda Ospedaliera Universitaria Integrata Verona | Verona , Italy, 37134Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas , Lithuania, 50161Kaunas City Polyclinic, Dainava Outpatient Clinic | Kaunas , Lithuania, 51270Klaipeda University Hospital | Klaipėda , Lithuania, 92288Hospital Selayang | Batu Caves , Malaysia, 68100University Malaya Medical Centre | Kuala Lumpur , Malaysia, 50603Klinik Kesihatan Kuang Lumpur | Kuala Lumpur , Malaysia, 53200Hospital Umum Sarawak | Kuching , Malaysia, 93586Klinik Kesihatan Masjid Tanah | Masjid Tanah , Malaysia, 78300Hospital Miri | Miri , Malaysia, 98000Klinik Kesihatan Kuang | Rawang , Malaysia, 48050Hospital Seri Manjung | Seri Manjung , Malaysia, 32040Southern Clinical Trials Totara | Auckland , New Zealand, 0600PCRN Silverdale Medical Centre | Auckland , New Zealand, 0932Aotearoa Clinical Trials | Auckland , New Zealand, 2025Pacific Clinical Research Network (PCRN) Clinical Trials | Christchurch , New Zealand, 8013Lakeland Clinical Trials Waikato | Hamilton , New Zealand, 3200Waikato Hospital | Hamilton , New Zealand, 3204Southern Clinical Trials Tasman | Nelson , New Zealand, 7011Pacific Clinical Research Network (PCRN) - Rotorua | Rotorua , New Zealand, 3010Lakeland Clinical Trials Wellington | Wellington , New Zealand, 5018Wellington Regional Hospital | Wellington , New Zealand, 6021Angeles University Foundation Medical Center | Angeles , Philippines, 2009Baguio General Hospital and Medical Center | Baguio City , Philippines, 2600Cebu Doctors' University Hospital | Cebu , Philippines, 6000De la Salle Medical and Health Sciences Institute | Dasmariñas , Philippines, 4114Davao Doctors Hospital | Davao City , Philippines, 8000Iloilo Doctors' Hospital Inc | Iloilo City , Philippines, 5000St. Paul's Hospital of Iloilo | Iloilo City , Philippines, 5000Lipa Medix Medical Center | Lipa , Philippines, 4217Ospital ng Makati | Makati , Philippines, 1210Makati Medical Center | Makati , Philippines, 1229Manila Doctors Hospital | Manila , Philippines, 1000Medical Center Manila | Manila , Philippines, 1000University of the Philippines - Philippine General Hospital | Manila , Philippines, 1000Chinese General Hospital and Medical Center | Manila , Philippines, 1014ClinicMed Daniluk, Nowak Spdtka komandytowa | Bialystok , Poland, 15-879Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska | Elblag , Poland, 82-300Malopolskie Centrum Kliniczne | Krakow , Poland, 30-149Pratia MCM Krakow | Krakow , Poland, 30-727Centrum Medyczne PROMED | Krakow , Poland, 31-513SOMED CR | Lodz , Poland, 90-368Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda | Lublin , Poland, 20-607ETYKA - Ośrodek Badań Klinicznych | Olsztyn , Poland, 10-117FutureMeds Warszawa Centrum | Warsaw , Poland, 00-215MICS Centrum Medyczne Warszawa | Warsaw , Poland, 00-874Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher | Warsaw , Poland, 02-637FutureMeds Targéwek | Warsaw , Poland, 03-291Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki | Wroclaw , Poland, 50-244Pusan National University Hospital | Busan , South Korea, 49241Keimyung University Dongsan hospital | Daegu , South Korea, 41931Chonnam National University Hospital | Gwangju , South Korea, 61469Jeju National University Hospital | Jeju City , South Korea, 63241Kyunghee University Hospital | Seoul , South Korea, 02447Hanyang University Hospital | Seoul , South Korea, 04763Asan Medical Center | Seoul , South Korea, 05505Gangnam Severance Hospital | Seoul , South Korea, 06273Uijeongbu Eulji Medical Cen | Uijeongbu-si , South Korea, 11759Hospital Universitario de A Coruña | A Coruña , Spain, 15006HM Hospital Nuestra Señora de la Esperanza | A Coruña , Spain, 15705Hospital Clinico Universitario de Santiago de Compostela (CHUS) | A Coruña , Spain, 15706Hospital Sanitas CIMA | Barcelona , Spain, 08034Hospital de La Santa Creu i Sant Pau | Barcelona , Spain, 08041Hospital de Bellvitge | Barcelona , Spain, 08907Hospital Universitario Reina Sofia | Córdoba , Spain, 14004Hospital Universitario Infanta Leonor | Madrid , Spain, 28031Hospital Universitario La Paz | Madrid , Spain, 28046Clinica Gaias Santiago | Santiago de Compostela , Spain, 15702Hospital Quirónsalud Sagrado Corazón | Seville , Spain, 41013Hospital do Meixoeiro | Vigo , Spain, 36214Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City , Taiwan, 83301Chung Shan Medical University Hospital | Taichung , Taiwan, 40201China Medical University Hospital | Taichung , Taiwan, 404327Taichung Veterans General Hospital | Taichung , Taiwan, 40705Chi Mei Medical Center | Tainan , Taiwan, 71004Chang Gung Medical Foundation - Linkou Chang Gung Memorial Hospital | Taoyuan City , Taiwan, 33305King Chulalongkorn Memorial Hospital | Bangkok , Thailand, 10330Phramongkutklao Hospital | Bangkok , Thailand, 10330Rajavithi Hospital | Bangkok , Thailand, 10400Ramathibodi Hospital | Bangkok , Thailand, 10400Siriraj Hospital | Bangkok , Thailand, 10700Maharaj Nakorn Chiang Mai Hospital | Chiang Mai , Thailand, 50200Thammasat University Hospital | Khlong Luang , Thailand, 12120Songklanagarind Hospital | Songkhla , Thailand, 90110 |
| Investigators | Study Director: Hyungjin Cho, MD, LG Chem |
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