Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05586971




Registration number
NCT05586971
Ethics application status
Date submitted
16/10/2022
Date registered
19/10/2022
Date last updated
22/07/2025

Titles & IDs
Public title
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Scientific 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
Secondary ID [1] 0 0
LG-GDCL010
Universal Trial Number (UTN)
Trial acronym
EURELIA2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Hyperuricemia 0 0
Gout Flare 0 0
Tophi 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tigulixostat
Treatment: Drugs - Allopurinol
Treatment: Drugs - Placebo

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

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

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

Active comparator: Titrated allopurinol (100-800mg) - 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.

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


Treatment: Drugs: Tigulixostat
Xanthine Oxidase Inhibitor

Treatment: Drugs: Allopurinol
Xanthine Oxidase Inhibitor

Treatment: Drugs: Placebo
Matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
Timepoint [1] 0 0
Up to Month 6
Secondary outcome [1] 0 0
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
Timepoint [1] 0 0
Up to Month 6
Secondary outcome [2] 0 0
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Timepoint [2] 0 0
From Month 6 to Month 12
Secondary outcome [3] 0 0
Proportion of subjects with complete resolution of =1 target tophus by Month 12
Timepoint [3] 0 0
Up to Month 12
Secondary outcome [4] 0 0
Incidence rate of adverse event
Timepoint [4] 0 0
Up to Month 12

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2025
Sample size
Target
Accrual to date
Final
2202
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Emeritus Research (Melbourne) - Camberwell
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [3] 0 0
Griffith University Clinical Trial Unit - Southport
Recruitment hospital [4] 0 0
Emeritus Research (Sydney) - Sydney
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4111 - Southport
Recruitment postcode(s) [4] 0 0
2019 - Sydney
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Córdoba
Country [34] 0 0
Argentina
State/province [34] 0 0
San Miguel de Tucumán
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Belgium
State/province [36] 0 0
Genk
Country [37] 0 0
Belgium
State/province [37] 0 0
Liège
Country [38] 0 0
Belgium
State/province [38] 0 0
Mons
Country [39] 0 0
Brazil
State/province [39] 0 0
Belo Horizonte
Country [40] 0 0
Brazil
State/province [40] 0 0
Curitiba
Country [41] 0 0
Brazil
State/province [41] 0 0
Juiz de Fora
Country [42] 0 0
Brazil
State/province [42] 0 0
Porto Alegre
Country [43] 0 0
Brazil
State/province [43] 0 0
Salvador
Country [44] 0 0
Brazil
State/province [44] 0 0
São Paulo
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Plovdiv
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Sofia
Country [47] 0 0
Colombia
State/province [47] 0 0
Bogotá
Country [48] 0 0
Colombia
State/province [48] 0 0
Bucaramanga
Country [49] 0 0
Colombia
State/province [49] 0 0
Manizales
Country [50] 0 0
Colombia
State/province [50] 0 0
Zipaquirá
Country [51] 0 0
Czechia
State/province [51] 0 0
Brno
Country [52] 0 0
Czechia
State/province [52] 0 0
Hlucín
Country [53] 0 0
Czechia
State/province [53] 0 0
New Town
Country [54] 0 0
Czechia
State/province [54] 0 0
Uherské Hradište
Country [55] 0 0
France
State/province [55] 0 0
Bordeaux
Country [56] 0 0
France
State/province [56] 0 0
Lomme
Country [57] 0 0
France
State/province [57] 0 0
Lyon
Country [58] 0 0
France
State/province [58] 0 0
Montpellier
Country [59] 0 0
France
State/province [59] 0 0
Orléans
Country [60] 0 0
France
State/province [60] 0 0
Rouen
Country [61] 0 0
Georgia
State/province [61] 0 0
Kutaisi
Country [62] 0 0
Georgia
State/province [62] 0 0
Tbilisi
Country [63] 0 0
Germany
State/province [63] 0 0
Berlin
Country [64] 0 0
Germany
State/province [64] 0 0
Deggingen
Country [65] 0 0
Germany
State/province [65] 0 0
Dresden
Country [66] 0 0
Germany
State/province [66] 0 0
Essen
Country [67] 0 0
Germany
State/province [67] 0 0
Hamburg
Country [68] 0 0
Germany
State/province [68] 0 0
Karlsruhe
Country [69] 0 0
Germany
State/province [69] 0 0
Schwerin
Country [70] 0 0
Italy
State/province [70] 0 0
Alessandria
Country [71] 0 0
Italy
State/province [71] 0 0
Milan
Country [72] 0 0
Italy
State/province [72] 0 0
Palermo
Country [73] 0 0
Italy
State/province [73] 0 0
Reggio Emilia
Country [74] 0 0
Italy
State/province [74] 0 0
Verona
Country [75] 0 0
Lithuania
State/province [75] 0 0
Kaunas
Country [76] 0 0
Lithuania
State/province [76] 0 0
Klaipeda
Country [77] 0 0
Malaysia
State/province [77] 0 0
Batu Caves
Country [78] 0 0
Malaysia
State/province [78] 0 0
Kuala Lumpur
Country [79] 0 0
Malaysia
State/province [79] 0 0
Kuching
Country [80] 0 0
Malaysia
State/province [80] 0 0
Masjid Tanah
Country [81] 0 0
Malaysia
State/province [81] 0 0
Miri
Country [82] 0 0
Malaysia
State/province [82] 0 0
Rawang
Country [83] 0 0
Malaysia
State/province [83] 0 0
Seri Manjung
Country [84] 0 0
New Zealand
State/province [84] 0 0
Auckland
Country [85] 0 0
New Zealand
State/province [85] 0 0
Christchurch
Country [86] 0 0
New Zealand
State/province [86] 0 0
Hamilton
Country [87] 0 0
New Zealand
State/province [87] 0 0
Nelson
Country [88] 0 0
New Zealand
State/province [88] 0 0
Rotorua
Country [89] 0 0
New Zealand
State/province [89] 0 0
Wellington
Country [90] 0 0
Philippines
State/province [90] 0 0
Angeles
Country [91] 0 0
Philippines
State/province [91] 0 0
Baguio City
Country [92] 0 0
Philippines
State/province [92] 0 0
Cebu
Country [93] 0 0
Philippines
State/province [93] 0 0
Dasmariñas
Country [94] 0 0
Philippines
State/province [94] 0 0
Davao City
Country [95] 0 0
Philippines
State/province [95] 0 0
Iloilo City
Country [96] 0 0
Philippines
State/province [96] 0 0
Lipa
Country [97] 0 0
Philippines
State/province [97] 0 0
Makati
Country [98] 0 0
Philippines
State/province [98] 0 0
Manila
Country [99] 0 0
Poland
State/province [99] 0 0
Bialystok
Country [100] 0 0
Poland
State/province [100] 0 0
Elblag
Country [101] 0 0
Poland
State/province [101] 0 0
Krakow
Country [102] 0 0
Poland
State/province [102] 0 0
Lodz
Country [103] 0 0
Poland
State/province [103] 0 0
Lublin
Country [104] 0 0
Poland
State/province [104] 0 0
Olsztyn
Country [105] 0 0
Poland
State/province [105] 0 0
Warsaw
Country [106] 0 0
Poland
State/province [106] 0 0
Wroclaw
Country [107] 0 0
South Korea
State/province [107] 0 0
Busan
Country [108] 0 0
South Korea
State/province [108] 0 0
Daegu
Country [109] 0 0
South Korea
State/province [109] 0 0
Gwangju
Country [110] 0 0
South Korea
State/province [110] 0 0
Jeju City
Country [111] 0 0
South Korea
State/province [111] 0 0
Seoul
Country [112] 0 0
South Korea
State/province [112] 0 0
Uijeongbu-si
Country [113] 0 0
Spain
State/province [113] 0 0
A Coruña
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
Córdoba
Country [116] 0 0
Spain
State/province [116] 0 0
Madrid
Country [117] 0 0
Spain
State/province [117] 0 0
Santiago de Compostela
Country [118] 0 0
Spain
State/province [118] 0 0
Seville
Country [119] 0 0
Spain
State/province [119] 0 0
Vigo
Country [120] 0 0
Taiwan
State/province [120] 0 0
Kaohsiung City
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taichung
Country [122] 0 0
Taiwan
State/province [122] 0 0
Tainan City
Country [123] 0 0
Taiwan
State/province [123] 0 0
Taoyuan
Country [124] 0 0
Thailand
State/province [124] 0 0
Bangkok
Country [125] 0 0
Thailand
State/province [125] 0 0
Chiang Mai
Country [126] 0 0
Thailand
State/province [126] 0 0
Khlong Luang
Country [127] 0 0
Thailand
State/province [127] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LG Chem
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hyungjin Cho, MD
Address 0 0
LG Chem
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05586971