A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia

LG-GDCL009

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

2022-10-25

2024-12-01

2025-06-01

Recruiting

Early phase I

350

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, 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) and rheumatoid arthritis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

2023-08-25