AzTrials
AzTrials

GoutPhase 3EURELIA2NCT05586971

Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

A Phase 3 study testing Tigulixostat and Allopurinol in people with Gout and Hyperuricemia, run by LG Chem at 279 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout, Hyperuricemia, Gout Flare
What is being tested?
Tigulixostat and Allopurinol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,202 participants
Where
279 sitesin 21 countries
Study dates
30 Mar 2023to 6 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

279 sites in 21 countries.

279 sites in 21 countries

United States124 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Long Island Regional Arthritis & Osteoporosis Care PC

    Babylon, New York, 11702

  • Velocity Clinical Research

    Banning, California, 92220

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Family Care Research, LLC

    Boise, Idaho, 83713

  • Cope Family Medicine/CCT Research

    Bountiful, Utah, 84010

  • American Clinical Trials

    Buena Park, California, 90620

  • Arizona Research Clinic, PLLC

    Chandler, Arizona, 85225

  • Presbyterian Hospital

    Charlotte, North Carolina, 28277

  • IMA Research, Inc.

    Chicago, Illinois, 60602

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • PCCR Solutions

    Colleyville, Texas, 76034

  • Centricity Research

    Columbus, Georgia, 31904

  • Herco Medical and Research Center, Inc

    Coral Gables, Florida, 33134

  • Clinical Trials Management, LLC

    Covington, Louisiana, 70433

  • Nouvelle Clinical Research LLC

    Cutler Bay, Florida, 33189

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • DFW Clinical Research

    Dallas, Texas, 75234

  • Alliance for Multispecialty Research, LLC

    Daphne, Alabama, 36526

  • Omega Research Debary, LLC

    DeBary, Florida, 32713

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Flagstaff, Arizona, 86001

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912

  • Dallas Fort Worth Clinical Research Associates

    Fort Worth, Texas, 76177

  • American Health Network of Indiana, LLC

    Franklin, Indiana, 46131

  • Methodist Physicians Clinic/CCT Research

    Fremont, Nebraska, 68025

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • Arizona Arthritis and Rheumatology Research PLLC

    Glendale, Arizona, 85306

  • Triad Clinical Trials, LLC

    Greensboro, North Carolina, 27410

  • Clinical Investigation Specialists, Inc

    Gurnee, Illinois, 60031

  • Hatboro Medical Associates, P.C.

    Hatboro, Pennsylvania, 19040

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Olympus Family Medicine

    Hendersonville, North Carolina, 28792

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Best Quality Research, Inc

    Hialeah, Florida, 33016

  • New Generation Of Medical Research, LLC

    Hialeah, Florida, 33016

  • Vital Pharma Research

    Hialeah, Florida, 33016

  • East West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • Elite Clinical Research, LLC

    Jackson, Mississippi, 39202

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114

  • Clay-Platte Family Medicine Clinic

    Kansas City, Missouri, 64151

  • New Phase Research

    Knoxville, Tennessee, 37909

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920

  • Accel Research Sites - Lakeland

    Lake Mary, Florida, 32746

  • Accel Research Sites - St. Petersburg- Largo

    Lake Mary, Florida, 32746

  • ARS-Matiland Clinical Research Unit

    Lake Mary, Florida, 32746

  • Shreenath Clinical Service

    Lakewood, California, 90805

  • Healor Primary Care /CCT Research

    Las Vegas, Nevada, 89102

  • Wake Research - CRCN

    Las Vegas, Nevada, 89118

  • Alliance for Multispecialty Research, LLC.

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Alliance for Multispecialty Research, LLC

    Meridian, Idaho, 83642

  • Arizon Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona, 85210

  • Desert Clinical Research/CCT Research

    Mesa, Arizona, 85213

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • Clinical Trials Management

    Metairie, Louisiana, 70006

  • Homestead Associates in Research,Inc

    Miami, Florida, 33032

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • D&H National Research Centers, Inc.

    Miami, Florida, 33155

  • Ivetmar Medical Group, LLC

    Miami, Florida, 33155

  • Care Research Center Inc

    Miami, Florida, 33175

  • Pharmax Research of South Florida, Inc

    Miami, Florida, 33175

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Clinical Site Partners, LLC dba Flourish Research

    Miami, Florida, 33186

  • M&A Medical Centers and Research

    Miami, Florida, 33186

  • Trinity Health Center Medical Arts

    Minot, North Dakota, 58701

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • American Health Network of Indiana LLC

    Muncie, Indiana, 47304

  • Syed Research Consultants, LLC

    Muscle Shoals, Alabama, 35661

  • IMA Clinical Research

    New York, New York, 10036

  • Vista Clinical Research, LLC

    Newnan, Georgia, 30265

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska, 68701

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • HMD Research LLC

    Orlando, Florida, 32819

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Arthritis Associates of Northwest Ohio Inc.

    Perrysburg, Ohio, 43551

  • Tristar Clinical Investigations, P.C.

    Philadelphia, Pennsylvania, 19114

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • AIM Trials, LLC

    Plano, Texas, 75093

  • Practice Dr David Headley

    Port Gibson, Mississippi, 39150

  • Meridian Clinical Research, LLC

    Portsmouth, Virginia, 23703

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • Olympus Family Medicine

    Salt Lake City, Utah, 84117

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • TriWest Research Associates

    San Diego, California, 92108

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • Inspire Santa Fe Medical Group

    Santa Fe, New Mexico, 87505

  • Women's & Family Care LLC, dba GTC Research

    Shawnee Mission, Kansas, 66218

  • Syed Research Consultants, LLC

    Sheffield, Alabama, 35660

  • Carolina Research Center, Inc.

    Shelby, North Carolina, 28150

  • South Ogden Family Medicine Clinic

    South Ogden, Utah, 84405

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • IMA Clinical Research

    St Louis, Missouri, 63117

  • St. Louis Medical Professionals, LLC

    St Louis, Missouri, 63119

  • IMA Clinical Research

    St. Petersburg, Florida, 33709

  • Sugar Lakes Family Practice, PA

    Sugar Land, Texas, 77479

  • Adult Medicine of Lake County, Inc.

    Tampa, Florida, 32757

  • Research Institute of South Florida, Inc.

    Tampa, Florida, 33173

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • Clinical Research Trials of Florida, Inc.

    Tampa, Florida, 33607

  • Nodal Medical Center

    Tampa, Florida, 33607

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Fiel Family and Sports Medicine/CCT Research

    Tempe, Arizona, 85283

  • DM Clinical Research

    Tomball, Texas, 77375

  • DM Clinical Research

    Tomball, Texas, 77377

  • STAT Research

    Vandalia, Ohio, 45377

  • Versailles Family Medicine

    Versailles, Kentucky, 40383

  • Conquest Research

    Vestal, New York, 13850

  • Integrated Clinical Trial Services Inc.

    West Des Moines, Iowa, 50265

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • Clinical Site Partners LLC dba CSP Orlando

    Winter Park, Florida, 32789

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Philippines14 sites

  • Angeles University Foundation Medical Center

    Angeles, 2009

  • Baguio General Hospital and Medical Center

    Baguio City, 2600

  • Cebu Doctors' University Hospital

    Cebu, 6000

  • De la Salle Medical and Health Sciences Institute

    Dasmariñas, 4114

  • Davao Doctors Hospital

    Davao City, 8000

  • Iloilo Doctors' Hospital Inc

    Iloilo City, 5000

  • St. Paul's Hospital of Iloilo

    Iloilo City, 5000

  • Lipa Medix Medical Center

    Lipa, 4217

  • Ospital ng Makati

    Makati, 1210

  • Makati Medical Center

    Makati, 1229

  • Manila Doctors Hospital

    Manila, 1000

  • Medical Center Manila

    Manila, 1000

  • University of the Philippines - Philippine General Hospital

    Manila, 1000

  • Chinese General Hospital and Medical Center

    Manila, 1014

Other trials in Philippines

Poland13 sites

  • ClinicMed Daniluk, Nowak Spdtka komandytowa

    Bialystok, 15-879

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

    Elblag, 82-300

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149

  • Pratia MCM Krakow

    Krakow, 30-727

  • Centrum Medyczne PROMED

    Krakow, 31-513

  • SOMED CR

    Lodz, 90-368

  • Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda

    Lublin, 20-607

  • ETYKA - Ośrodek Badań Klinicznych

    Olsztyn, 10-117

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

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

    Warsaw, 02-637

  • FutureMeds Targéwek

    Warsaw, 03-291

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

    Wroclaw, 50-244

Other trials in Poland

Argentina12 sites

  • Hospital Universitario Austral

    Buenos Aires, B1635

  • Instituto de Investigaciones Clinicas San Nicolás

    Buenos Aires, B2900

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

    Buenos Aires, C1015

  • Aprillus Asistencia e Investigacion Clinica

    Buenos Aires, C1406A

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG

  • Clinica Adventista Belgrano

    Buenos Aires, C1430EGF

  • Instituto de Investigaciones Clinicas Cordoba

    Córdoba, X5000AAW

  • Centro Integral De Dianogostico por Imagenes Marchegiani (CIDIM)

    Córdoba, X5000AVE

  • Instituto Reumatologico Strusberg

    Córdoba, X5000EOC

  • Clinica Privada Velez Sarsfield (CPVS)

    Córdoba, X5016LIG

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000

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

    Santa Fe, S2000PBJ

Other trials in Argentina

Spain12 sites

  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • HM Hospital Nuestra Señora de la Esperanza

    A Coruña, 15705

  • Hospital Clinico Universitario de Santiago de Compostela (CHUS)

    A Coruña, 15706

  • Hospital Sanitas CIMA

    Barcelona, 08034

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital de Bellvitge

    Barcelona, 08907

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Gaias Santiago

    Santiago de Compostela, 15702

  • Hospital Quirónsalud Sagrado Corazón

    Seville, 41013

  • Hospital do Meixoeiro

    Vigo, 36214

Other trials in Spain

New Zealand10 sites

  • Southern Clinical Trials Totara

    Auckland, 0600

  • PCRN Silverdale Medical Centre

    Auckland, 0932

  • Aotearoa Clinical Trials

    Auckland, 2025

  • Pacific Clinical Research Network (PCRN) Clinical Trials

    Christchurch, 8013

  • Lakeland Clinical Trials Waikato

    Hamilton, 3200

  • Waikato Hospital

    Hamilton, 3204

  • Southern Clinical Trials Tasman

    Nelson, 7011

  • Pacific Clinical Research Network (PCRN) - Rotorua

    Rotorua, 3010

  • Lakeland Clinical Trials Wellington

    Wellington, 5018

  • Wellington Regional Hospital

    Wellington, 6021

Other trials in New Zealand

South Korea9 sites

  • Pusan National University Hospital

    Busan, 49241

  • Keimyung University Dongsan hospital

    Daegu, 41931

  • Chonnam National University Hospital

    Gwangju, 61469

  • Jeju National University Hospital

    Jeju City, 63241

  • Kyunghee University Hospital

    Seoul, 02447

  • Hanyang University Hospital

    Seoul, 04763

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Uijeongbu Eulji Medical Cen

    Uijeongbu-si, 11759

Other trials in South Korea

Brazil8 sites

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, 30150-221

  • CETI - Centro de Estudos em Terapias Inovadoras

    Curitiba, 80030-110

  • EDUMED - Educação em Saúde S/S Ltda

    Curitiba, 80440-080

  • LMK Serviços Médicos Sociedade Simples

    Curitiba, 90480-000

  • CMIP-Centro Mineiro de Pesquisa

    Juiz de Fora, 36010-570

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • SER - Serviços Especializados em Reumatologia da Bahia

    Salvador, 40150-150

  • Clinica Medica Bonfiflioli Ltda

    São Paulo, 13015-001

Other trials in Brazil

Bulgaria8 sites

  • University Multiprofile Hospital for Active Treatment Plovdiv "Eurohospital" Ltd

    Plovdiv, 4004

  • Mbal Lyulin EAD

    Sofia, 1336

  • Medical Center Excelsior OOD

    Sofia, 1407

  • DCC Fokus-5 Lzip OOD

    Sofia, 1463

  • Medical Center-N.I. Pirogov EOOD

    Sofia, 1606

  • Military medical academy

    Sofia, 1606

  • Acibadem City Clinic Diagnostic And Consultation Center Ltd

    Sofia, 1784

  • Medical Center Synexus Sofia EOOD

    Sofia, 1784

Other trials in Bulgaria

Georgia8 sites

  • "LJ Clinic" LTD

    Kutaisi, 4600

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102

  • LTD "Israeli-Georgian Medical Research Clinic Helsicore"

    Tbilisi, 0112

  • Cardioclinic - Digomi Medical Center

    Tbilisi, 0159

  • JSC "Evex Hospitals"

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, 0159

  • LTD MediClub Georgia

    Tbilisi, 0160

  • Multiprofile Clinic Consilium Medula LTD

    Tbilisi, 0186

Other trials in Georgia

Germany8 sites

  • Emovis GmbH

    Berlin, 10629

  • Gemeinschaftspraxis Dres. T. und N. Jung

    Deggingen, 73326

  • Klinische Forschung Dresden GmbH

    Dresden, 01069

  • Medizentrum Essen Borbeck

    Essen, 45355

  • Velocity Clincial Research Hamburg GmbH

    Hamburg, 22143

  • Praxis für klinische Studien

    Hamburg, 22415

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe, 76137

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Malaysia8 sites

  • Hospital Selayang

    Batu Caves, 68100

  • University Malaya Medical Centre

    Kuala Lumpur, 50603

  • Klinik Kesihatan Kuang Lumpur

    Kuala Lumpur, 53200

  • Hospital Umum Sarawak

    Kuching, 93586

  • Klinik Kesihatan Masjid Tanah

    Masjid Tanah, 78300

  • Hospital Miri

    Miri, 98000

  • Klinik Kesihatan Kuang

    Rawang, 48050

  • Hospital Seri Manjung

    Seri Manjung, 32040

Other trials in Malaysia

Thailand8 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Phramongkutklao Hospital

    Bangkok, 10330

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Thammasat University Hospital

    Khlong Luang, 12120

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

France6 sites

  • CHU De Bordeaux

    Bordeaux, 33076

  • Hôpital Saint Philibert

    Lomme, 59160

  • Hôpital Edourad Herriot

    Lyon, 69003

  • Hôpital Lapeyronie

    Montpellier, 34295

  • Centre Hospitalier Regional D'Orleans

    Orléans, 45067

  • CHU Hôpitaux De Rouen

    Rouen, 76031

Other trials in France

Taiwan6 sites

  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • China Medical University Hospital

    Taichung, 404327

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi Mei Medical Center

    Tainan, 71004

  • Chang Gung Medical Foundation - Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33305

Other trials in Taiwan

Australia5 sites

  • Emeritus Research (Melbourne)

    Camberwell, 3124

  • Holdsworth House Medical Practice

    Darlinghurst, 2010

  • Griffith University Clinical Trial Unit

    Southport, 4111

  • Emeritus Research (Sydney)

    Sydney, 2019

  • The Queen Elizabeth Hospital

    Woodville South, 5011

Other trials in Australia

Czechia5 sites

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

    Brno, 602 00

  • REVMACLINIC s.r.o.

    Brno, 611 41

  • L.K.N Arthrocentrum

    Hlučín, 748 01

  • Revmatologicky ustav

    New Town, 128 50

  • MEDICAL PLUS s.r.o.

    Uherské Hradiště, 686 01

Other trials in Czechia

Italy5 sites

  • Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria

    Alessandria, 15121

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    Milan, 20157

  • AOU Policlinico Paolo Giaccone

    Palermo, 90127

  • AUSL di Reggio Emilia, Arcispedale Santa Maria Nuova-IRCCS

    Reggio Emilia, 42123

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

Other trials in Italy

Colombia4 sites

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

    Bogotá, 110221

  • Servimed S.A.S.

    Bucaramanga, 680003

  • IPS Medicos Internistas de Caldas SAS

    Manizales, 170004

  • Healthy Medical Center SAS

    Zipaquirá, 250252

Other trials in Colombia

Belgium3 sites

  • ReumaClinic

    Genk, 3600

  • CHU de Liège

    Liège, 4000

  • CHU HELORA - Hôpital de Mons - Site Kenedy

    Mons, 7000

Other trials in Belgium

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161

  • Kaunas City Polyclinic, Dainava Outpatient Clinic

    Kaunas, 51270

  • Klaipeda University Hospital

    Klaipėda, 92288

Other trials in Lithuania

About this study

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

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.

Being tested
Tigulixostat, Allopurinol, Placebo
Keywords
Gout, Hyperuricemia, Xanthine Oxidase Inhibitor
Medical subject headings
Gout, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TigulixostatDrug

    Also called LC350189

    Xanthine Oxidase Inhibitor

  • AllopurinolDrug

    Xanthine Oxidase Inhibitor

  • PlaceboDrug

    Matching placebo

Study groups in NCT05586971
Study groupRoleWhat they receive
Tigulixostat 100mgExperimentalTigulixostat 100mg, Once a day (QD) for up to 12 months
Receives: Drug: Tigulixostat
Tigulixostat 200mgExperimentalTigulixostat 200mg, Once a day (QD) for up to 12 months
Receives: Drug: Tigulixostat
Tigulixostat 300mgExperimentalTigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
Receives: Drug: Tigulixostat
Titrated allopurinol (100-800mg)Active comparatorAllopurinol 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.
Receives: Drug: Allopurinol
PlaceboPlacebo comparatorPlacebo, three times a day (TID) for up to 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to Month 6

Secondary outcomes (4)

  1. 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

    Measured: Up to Month 6

  2. 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

    Measured: From Month 6 to Month 12

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

    Tophi will be measured by independent central blind reader

    Measured: Up to Month 12

  4. Incidence rate of adverse event

    Safety assessment

    Measured: Up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start30 Mar 2023
  3. Primary completion6 May 2025
  4. Study completion6 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586971
Sponsor's protocol ID
LG-GDCL010
Acronym
EURELIA2
Status last verified
Jul 2025
First submitted
16 Oct 2022
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39929260

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tigulixostat and Allopurinol in people with Gout and Hyperuricemia, run by LG Chem at 279 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 279 sites in United States, Philippines, Poland, Argentina, Spain and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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