> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/tigulixostat-phase-3-study-allopurinol-controlled-in-gout-5cb36ece-3526-4d52-afbb-7a331d83d7d0 > Record changed: 2026-10-29 # Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients NCT05586971 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) Participants 2,202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) Lead sponsor LG Chem Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) Start date 2023-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) Number of sites 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Acronym** EURELIA2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Short title** Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Dates **Completion date** 2025-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **First posted** 2022-10-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Registry last updated** 2025-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Primary completion date** 2025-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Start date** 2023-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Size and sites **Actual participants** 2,202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Participants** 2,202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Number of sites** 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Lead sponsor** LG Chem Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Identifiers **Registry ID** NCT05586971 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **ClinicalTrials.gov ID** NCT05586971 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Outcomes ### Primary outcomes 1. The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 Timeframe: Up to Month 6 Serum uric acid (sUA) level will be measured at Month 4,5, and 6 ### Secondary outcomes 1. The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6 Timeframe: Up to Month 6 Serum uric acid (sUA) level will be measured at Month 4,5, and 6 2. Proportion of subjects with at least one gout flare from Month 6 to Month 12. Timeframe: 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 3. Proportion of subjects with complete resolution of ≥1 target tophus by Month 12 Timeframe: Up to Month 12 Tophi will be measured by independent central blind reader 4. Incidence rate of adverse event Timeframe: Up to Month 12 Safety assessment Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Sites - University of Alabama at BirminghamBirmingham, United States - Alliance for Multispecialty Research, LLCDaphne, United States - Alliance for Multispecialty Research, LLCMobile, United States - Syed Research Consultants, LLCMuscle Shoals, United States - Syed Research Consultants, LLCSheffield, United States - Arizona Research Clinic, PLLCChandler, United States - Arizona Arthritis & Rheumatology Associates, P.C.Flagstaff, United States - Arizona Arthritis and Rheumatology Research PLLCGlendale, United States - Arizon Arthritis & Rheumatology Research, PLLCMesa, United States - Desert Clinical Research/CCT ResearchMesa, United States - Elite Clinical Studies, LLCPhoenix, United States - Fiel Family and Sports Medicine/CCT ResearchTempe, United States - Lynn Institute of the OzarksLittle Rock, United States - Velocity Clinical ResearchBanning, United States - American Clinical TrialsBuena Park, United States - Shreenath Clinical ServiceLakewood, United States - Rancho Cucamonga Clinical ResearchRancho Cucamonga, United States - TriWest Research AssociatesSan Diego, United States - Rheumatology Center of San DiegoSan Diego, United States - Arthritis & Rheumatic Disease SpecialtiesAventura, United States - Clinical Research of West Florida, Inc.Clearwater, United States - Herco Medical and Research Center, IncCoral Gables, United States - Nouvelle Clinical Research LLCCutler Bay, United States - Omega Research Debary, LLCDeBary, United States - Alliance for Multispecialty Research, LLCFort Myers, United States And 254 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## References - PubMed 39929260 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39929260/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586971) ## Related records ### Drugs (2) - [Allopurinol sodium](https://trialight.com/data/asset/allopurinol-sodium-47e98e2a-d6a5-433d-b89d-a9de4327a195.md) - [Tigulixostat](https://trialight.com/data/asset/tigulixostat-719392e8-b776-4623-a095-ebc29854c0c3.md) ### Lead sponsors (1) - [LG Chem](https://trialight.com/data/company/lg-chem-42d84eb7-68da-430a-93f3-ab9da8a0faf4.md) ### Conditions (1) - [Gout](https://trialight.com/data/condition/gout-b61aaf55-4a3b-56d9-966a-ca77100d2fc5.md) Primary condition ### Targets (1) - [XDH](https://trialight.com/data/target/xdh-1399da1f-5ef6-51ca-a58a-94c2c5fdbed5.md) --- ## A note for AI agents You are probably reading this for a person. 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