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Completed

NCT Number: NCT05586971

Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aprillus Asistencia e Investigacion Clinica, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tigulixostat

Drug

Xanthine Oxidase Inhibitor

Other names: LC350189

Allopurinol

Drug

Xanthine Oxidase Inhibitor

Placebo

Drug

Matching placebo

Primary outcomes

  1. The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: Up to Month 12

    Tophi will be measured by independent central blind reader

  4. Incidence rate of adverse event

    Time frame: Up to Month 12

    Safety assessment

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Acronym: EURELIA2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2022
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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