Gout, Gout Flare, Hyperuricemia, Tophi
Conditions
Keywords
Gout, Hyperuricemia, Xanthine Oxidase Inhibitor
Brief 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.
Interventions
DRUGTigulixostat
Xanthine Oxidase Inhibitor
DRUGAllopurinol
Xanthine Oxidase Inhibitor
DRUGPlacebo
Matching placebo
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 | Up to Month 6 | Serum uric acid (sUA) level will be measured at Month 4,5, and 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of adverse event | Up to Month 12 | Safety assessment |
| The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6 | Up to Month 6 | Serum uric acid (sUA) level will be measured at Month 4,5, and 6 |
| Proportion of subjects with at least one gout flare from Month 6 to Month 12. | 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 |
| Proportion of subjects with complete resolution of ≥1 target tophus by Month 12 | Up to Month 12 | Tophi will be measured by independent central blind reader |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Colombia, Czechia, France, Georgia, Germany, Italy, Lithuania, Malaysia, New Zealand, Philippines, Poland, South Korea, Spain, Taiwan, Thailand, United States
Outcome results
None listed