Last updated 14 months ago
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
2542 patients around the world
Available in United States, Argentina
LG Chem
2Research sites
2542Patients around the world
This study is for people with
Gout
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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).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).
- 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).
Sites
Instituto Médico Strusberg - Córdoba
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
StudyEURELIA2
SponsorLG Chem
Conditions
Gout
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05586971
