Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

NCT05586971 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: LG-GDCL010
• Study Type: interventional
• Target: 2,202
• Locations: 21 countries
• Sites: 279

Brief 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.

Conditions

Gout; Hyperuricemia; Gout Flare; Tophi

Keywords

Gout; Hyperuricemia; Xanthine Oxidase Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6

  Up to Month 6

• Proportion of subjects with at least one gout flare from Month 6 to Month 12.

  From Month 6 to Month 12

• Proportion of subjects with complete resolution of ≥1 target tophus by Month 12

  Up to Month 12

• Incidence rate of adverse event

  Up to Month 12

Study Arms (5)

Tigulixostat 100mg

EXPERIMENTAL

Tigulixostat 100mg, Once a day (QD) for up to 12 months

Drug: Tigulixostat

Tigulixostat 200mg

EXPERIMENTAL

Tigulixostat 200mg, Once a day (QD) for up to 12 months

Drug: Tigulixostat

Tigulixostat 300mg

EXPERIMENTAL

Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months

Drug: Tigulixostat

Titrated allopurinol (100-800mg)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo, three times a day (TID) for up to 6 months.

Drug: Placebo

Interventions

Tigulixostat DRUG

Xanthine Oxidase Inhibitor

Also known as: LC350189

Tigulixostat 100mg; Tigulixostat 200mg; Tigulixostat 300mg

Allopurinol DRUG

Xanthine Oxidase Inhibitor

Titrated allopurinol (100-800mg)

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 & Collaborators

• LG Chem: lead

Study Sites (279)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Alliance for Multispecialty Research, LLC

Daphne, Alabama, 36526, United States

Location

Alliance for Multispecialty Research, LLC

Mobile, Alabama, 36608, United States

Location

Syed Research Consultants, LLC

Muscle Shoals, Alabama, 35661, United States

Location

Syed Research Consultants, LLC

Sheffield, Alabama, 35660, United States

Location

Arizona Research Clinic, PLLC

Chandler, Arizona, 85225, United States

Location

Arizona Arthritis & Rheumatology Associates, P.C.

Flagstaff, Arizona, 86001, United States

Location

Arizona Arthritis and Rheumatology Research PLLC

Glendale, Arizona, 85306, United States

Location

Arizon Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States

Location

Desert Clinical Research/CCT Research

Mesa, Arizona, 85213, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Fiel Family and Sports Medicine/CCT Research

Tempe, Arizona, 85283, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72204, United States

Location

Velocity Clinical Research

Banning, California, 92220, United States

Location

American Clinical Trials

Buena Park, California, 90620, United States

Location

Shreenath Clinical Service

Lakewood, California, 90805, United States

Location

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, 91730, United States

Location

TriWest Research Associates

San Diego, California, 92108, United States

Location

Rheumatology Center of San Diego

San Diego, California, 92128, United States

Location

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Herco Medical and Research Center, Inc

Coral Gables, Florida, 33134, United States

Location

Nouvelle Clinical Research LLC

Cutler Bay, Florida, 33189, United States

Location

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

Location

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, 33912, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Best Quality Research, Inc

Hialeah, Florida, 33016, United States

Location

New Generation Of Medical Research, LLC

Hialeah, Florida, 33016, United States

Location

Vital Pharma Research

Hialeah, Florida, 33016, United States

Location

Accel Research Sites - Lakeland

Lake Mary, Florida, 32746, United States

Location

Accel Research Sites - St. Petersburg- Largo

Lake Mary, Florida, 32746, United States

Location

ARS-Matiland Clinical Research Unit

Lake Mary, Florida, 32746, United States

Location

Homestead Associates in Research,Inc

Miami, Florida, 33032, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

D&H National Research Centers, Inc.

Miami, Florida, 33155, United States

Location

Ivetmar Medical Group, LLC

Miami, Florida, 33155, United States

Location

Care Research Center Inc

Miami, Florida, 33175, United States

Location

Pharmax Research of South Florida, Inc

Miami, Florida, 33175, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Miami, Florida, 33186, United States

Location

M&A Medical Centers and Research

Miami, Florida, 33186, United States

Location

HMD Research LLC

Orlando, Florida, 32819, United States

Location

IMA Clinical Research

St. Petersburg, Florida, 33709, United States

Location

Adult Medicine of Lake County, Inc.

Tampa, Florida, 32757, United States

Location

Research Institute of South Florida, Inc.

Tampa, Florida, 33173, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

Nodal Medical Center

Tampa, Florida, 33607, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Clinical Site Partners LLC dba CSP Orlando

Winter Park, Florida, 32789, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Arthritis Center of North Georgia

Gainesville, Georgia, 30501, United States

Location

Vista Clinical Research, LLC

Newnan, Georgia, 30265, United States

Location

East West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Family Care Research, LLC

Boise, Idaho, 83713, United States

Location

Alliance for Multispecialty Research, LLC

Meridian, Idaho, 83642, United States

Location

IMA Research, Inc.

Chicago, Illinois, 60602, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422, United States

Location

Clinical Investigation Specialists, Inc

Gurnee, Illinois, 60031, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

American Health Network of Indiana, LLC

Franklin, Indiana, 46131, United States

Location

American Health Network of Indiana LLC

Muncie, Indiana, 47304, United States

Location

Integrated Clinical Trial Services Inc.

West Des Moines, Iowa, 50265, United States

Location

Women's & Family Care LLC, dba GTC Research

Shawnee Mission, Kansas, 66218, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Versailles Family Medicine

Versailles, Kentucky, 40383, United States

Location

Clinical Trials Management, LLC

Covington, Louisiana, 70433, United States

Location

Clinical Trials Management

Metairie, Louisiana, 70006, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Elite Clinical Research, LLC

Jackson, Mississippi, 39202, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

Practice Dr David Headley

Port Gibson, Mississippi, 39150, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, 64114, United States

Location

Clay-Platte Family Medicine Clinic

Kansas City, Missouri, 64151, United States

Location

IMA Clinical Research

St Louis, Missouri, 63117, United States

Location

St. Louis Medical Professionals, LLC

St Louis, Missouri, 63119, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Methodist Physicians Clinic/CCT Research

Fremont, Nebraska, 68025, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Healor Primary Care /CCT Research

Las Vegas, Nevada, 89102, United States

Location

Wake Research - CRCN

Las Vegas, Nevada, 89118, United States

Location

Alliance for Multispecialty Research, LLC.

Las Vegas, Nevada, 89119, United States

Location

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

Inspire Santa Fe Medical Group

Santa Fe, New Mexico, 87505, United States

Location

Long Island Regional Arthritis & Osteoporosis Care PC

Babylon, New York, 11702, United States

Location

IMA Clinical Research

New York, New York, 10036, United States

Location

Conquest Research

Vestal, New York, 13850, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28277, United States

Location

Triad Clinical Trials, LLC

Greensboro, North Carolina, 27410, United States

Location

Olympus Family Medicine

Hendersonville, North Carolina, 28792, United States

Location

Burke Primary Care

Morganton, North Carolina, 28655, United States

Location

Carolina Research Center, Inc.

Shelby, North Carolina, 28150, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Trinity Health Center Medical Arts

Minot, North Dakota, 58701, United States

Location

Arthritis Associates of Northwest Ohio Inc.

Perrysburg, Ohio, 43551, United States

Location

STAT Research

Vandalia, Ohio, 45377, United States

Location

Hatboro Medical Associates, P.C.

Hatboro, Pennsylvania, 19040, United States

Location

Tristar Clinical Investigations, P.C.

Philadelphia, Pennsylvania, 19114, United States

Location

New Phase Research

Knoxville, Tennessee, 37909, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

PCCR Solutions

Colleyville, Texas, 76034, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

DFW Clinical Research

Dallas, Texas, 75234, United States

Location

Dallas Fort Worth Clinical Research Associates

Fort Worth, Texas, 76177, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Sugar Lakes Family Practice, PA

Sugar Land, Texas, 77479, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

DM Clinical Research

Tomball, Texas, 77377, United States

Location

Cope Family Medicine/CCT Research

Bountiful, Utah, 84010, United States

Location

Olympus Family Medicine

Salt Lake City, Utah, 84117, United States

Location

Highland Clinical Research

Salt Lake City, Utah, 84124, United States

Location

South Ogden Family Medicine Clinic

South Ogden, Utah, 84405, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Meridian Clinical Research, LLC

Portsmouth, Virginia, 23703, United States

Location

Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States

Location

Arthritis Northwest, PLLC

Spokane, Washington, 99204, United States

Location

Hospital Universitario Austral

Buenos Aires, B1635, Argentina

Location

Instituto de Investigaciones Clinicas San Nicolás

Buenos Aires, B2900, Argentina

Location

Centro Médico Reumatologico - Organizacion Medica de Investigacion S.A. (OMI)

Buenos Aires, C1015, Argentina

Location

Aprillus Asistencia e Investigacion Clinica

Buenos Aires, C1406A, Argentina

Location

Centro Privado de Medicina Familiar

Buenos Aires, C1417EYG, Argentina

Location

Clinica Adventista Belgrano

Buenos Aires, C1430EGF, Argentina

Location

Instituto de Investigaciones Clinicas Cordoba

Córdoba, X5000AAW, Argentina

Location

Centro Integral De Dianogostico por Imagenes Marchegiani (CIDIM)

Córdoba, X5000AVE, Argentina

Location

Instituto Reumatologico Strusberg

Córdoba, X5000EOC, Argentina

Location

Clinica Privada Velez Sarsfield (CPVS)

Córdoba, X5016LIG, Argentina

Location

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, T4000, Argentina

Location

Instituto CAICI (Instituto Centralizado de Asistencia e Investigacion Clinica Integral)

Santa Fe, S2000PBJ, Argentina

Location

Emeritus Research (Melbourne)

Camberwell, 3124, Australia

Location

Holdsworth House Medical Practice

Darlinghurst, 2010, Australia

Location

Griffith University Clinical Trial Unit

Southport, 4111, Australia

Location

Emeritus Research (Sydney)

Sydney, 2019, Australia

Location

The Queen Elizabeth Hospital

Woodville South, 5011, Australia

Location

ReumaClinic

Genk, 3600, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

CHU HELORA - Hôpital de Mons - Site Kenedy

Mons, 7000, Belgium

Location

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, 30150-221, Brazil

Location

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, 80030-110, Brazil

Location

EDUMED - Educação em Saúde S/S Ltda

Curitiba, 80440-080, Brazil

Location

LMK Serviços Médicos Sociedade Simples

Curitiba, 90480-000, Brazil

Location

CMIP-Centro Mineiro de Pesquisa

Juiz de Fora, 36010-570, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

SER - Serviços Especializados em Reumatologia da Bahia

Salvador, 40150-150, Brazil

Location

Clinica Medica Bonfiflioli Ltda

São Paulo, 13015-001, Brazil

Location

University Multiprofile Hospital for Active Treatment Plovdiv "Eurohospital" Ltd

Plovdiv, 4004, Bulgaria

Location

Mbal Lyulin EAD

Sofia, 1336, Bulgaria

Location

Medical Center Excelsior OOD

Sofia, 1407, Bulgaria

Location

DCC Fokus-5 Lzip OOD

Sofia, 1463, Bulgaria

Location

Medical Center-N.I. Pirogov EOOD

Sofia, 1606, Bulgaria

Location

Military medical academy

Sofia, 1606, Bulgaria

Location

Acibadem City Clinic Diagnostic And Consultation Center Ltd

Sofia, 1784, Bulgaria

Location

Medical Center Synexus Sofia EOOD

Sofia, 1784, Bulgaria

Location

Centro de Investigacion en Reumatología y Especialidades Médicas S.A.S (CIREEM S.A.S)

Bogotá, 110221, Colombia

Location

Servimed S.A.S.

Bucaramanga, 680003, Colombia

Location

IPS Medicos Internistas de Caldas SAS

Manizales, 170004, Colombia

Location

Healthy Medical Center SAS

Zipaquirá, 250252, Colombia

Location

MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.

Brno, 602 00, Czechia

Location

REVMACLINIC s.r.o.

Brno, 611 41, Czechia

Location

L.K.N Arthrocentrum

Hlučín, 748 01, Czechia

Location

Revmatologicky ustav

New Town, 128 50, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, 686 01, Czechia

Location

CHU De Bordeaux

Bordeaux, 33076, France

Location

Hôpital Saint Philibert

Lomme, 59160, France

Location

Hôpital Edourad Herriot

Lyon, 69003, France

Location

Hôpital Lapeyronie

Montpellier, 34295, France

Location

Centre Hospitalier Regional D'Orleans

Orléans, 45067, France

Location

CHU Hôpitaux De Rouen

Rouen, 76031, France

Location

"LJ Clinic" LTD

Kutaisi, 4600, Georgia

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

Location

LTD "Israeli-Georgian Medical Research Clinic Helsicore"

Tbilisi, 0112, Georgia

Location

Cardioclinic - Digomi Medical Center

Tbilisi, 0159, Georgia

Location

JSC "Evex Hospitals"

Tbilisi, 0159, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

LTD MediClub Georgia

Tbilisi, 0160, Georgia

Location

Multiprofile Clinic Consilium Medula LTD

Tbilisi, 0186, Georgia

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Gemeinschaftspraxis Dres. T. und N. Jung

Deggingen, 73326, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Medizentrum Essen Borbeck

Essen, 45355, Germany

Location

Velocity Clincial Research Hamburg GmbH

Hamburg, 22143, Germany

Location

Praxis für klinische Studien

Hamburg, 22415, Germany

Location

Klinische Forschung Karlsruhe GmbH

Karlsruhe, 76137, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria

Alessandria, 15121, Italy

Location

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, 20157, Italy

Location

AOU Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

AUSL di Reggio Emilia, Arcispedale Santa Maria Nuova-IRCCS

Reggio Emilia, 42123, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37134, Italy

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

Location

Kaunas City Polyclinic, Dainava Outpatient Clinic

Kaunas, 51270, Lithuania

Location

Klaipeda University Hospital

Klaipėda, 92288, Lithuania

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

Klinik Kesihatan Kuang Lumpur

Kuala Lumpur, 53200, Malaysia

Location

Hospital Umum Sarawak

Kuching, 93586, Malaysia

Location

Klinik Kesihatan Masjid Tanah

Masjid Tanah, 78300, Malaysia

Location

Hospital Miri

Miri, 98000, Malaysia

Location

Klinik Kesihatan Kuang

Rawang, 48050, Malaysia

Location

Hospital Seri Manjung

Seri Manjung, 32040, Malaysia

Location

Southern Clinical Trials Totara

Auckland, 0600, New Zealand

Location

PCRN Silverdale Medical Centre

Auckland, 0932, New Zealand

Location

Aotearoa Clinical Trials

Auckland, 2025, New Zealand

Location

Pacific Clinical Research Network (PCRN) Clinical Trials

Christchurch, 8013, New Zealand

Location

Lakeland Clinical Trials Waikato

Hamilton, 3200, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Southern Clinical Trials Tasman

Nelson, 7011, New Zealand

Location

Pacific Clinical Research Network (PCRN) - Rotorua

Rotorua, 3010, New Zealand

Location

Lakeland Clinical Trials Wellington

Wellington, 5018, New Zealand

Location

Wellington Regional Hospital

Wellington, 6021, New Zealand

Location

Angeles University Foundation Medical Center

Angeles, 2009, Philippines

Location

Baguio General Hospital and Medical Center

Baguio City, 2600, Philippines

Location

Cebu Doctors' University Hospital

Cebu, 6000, Philippines

Location

De la Salle Medical and Health Sciences Institute

Dasmariñas, 4114, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

Iloilo Doctors' Hospital Inc

Iloilo City, 5000, Philippines

Location

St. Paul's Hospital of Iloilo

Iloilo City, 5000, Philippines

Location

Lipa Medix Medical Center

Lipa, 4217, Philippines

Location

Ospital ng Makati

Makati, 1210, Philippines

Location

Makati Medical Center

Makati, 1229, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

Medical Center Manila

Manila, 1000, Philippines

Location

University of the Philippines - Philippine General Hospital

Manila, 1000, Philippines

Location

Chinese General Hospital and Medical Center

Manila, 1014, Philippines

Location

ClinicMed Daniluk, Nowak Spdtka komandytowa

Bialystok, 15-879, Poland

Location

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

Elblag, 82-300, Poland

Location

Malopolskie Centrum Kliniczne

Krakow, 30-149, Poland

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-513, Poland

Location

SOMED CR

Lodz, 90-368, Poland

Location

Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda

Lublin, 20-607, Poland

Location

ETYKA - Ośrodek Badań Klinicznych

Olsztyn, 10-117, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, 00-215, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00-874, Poland

Location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, 02-637, Poland

Location

FutureMeds Targéwek

Warsaw, 03-291, Poland

Location

Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki

Wroclaw, 50-244, Poland

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Keimyung University Dongsan hospital

Daegu, 41931, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Jeju National University Hospital

Jeju City, 63241, South Korea

Location

Kyunghee University Hospital

Seoul, 02447, South Korea

Location

Hanyang University Hospital

Seoul, 04763, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Uijeongbu Eulji Medical Cen

Uijeongbu-si, 11759, South Korea

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

HM Hospital Nuestra Señora de la Esperanza

A Coruña, 15705, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela (CHUS)

A Coruña, 15706, Spain

Location

Hospital Sanitas CIMA

Barcelona, 08034, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Clinica Gaias Santiago

Santiago de Compostela, 15702, Spain

Location

Hospital Quirónsalud Sagrado Corazón

Seville, 41013, Spain

Location

Hospital do Meixoeiro

Vigo, 36214, Spain

Location

Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

China Medical University Hospital

Taichung, 404327, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chi Mei Medical Center

Tainan, 71004, Taiwan

Location

Chang Gung Medical Foundation - Linkou Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital

Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Thammasat University Hospital

Khlong Luang, 12120, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Related Publications (1)

• 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.

  PMID: 39929260 DERIVED

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hyungjin Cho, MD

  LG Chem

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: March 30, 2023
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); MY (8); PL (13); CO (4); BU (8); TW (6); AR (12); DE (8); TH (8); NZ (10); BE (3); GE (8); BR (8); LI (3); CZ (5); FR (6); KR (9); IT (5); ES (12); US (124); PH (14)