Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LG Chem
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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).
