Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
- Conditions
- GoutHyperuricemiaGout FlareTophi
- Interventions
- Drug: Placebo
- Registration Number
- NCT05586958
- Lead Sponsor
- LG Chem
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tigulixostat 100mg Tigulixostat Tigulixostat 100mg, Once a day (QD) for up to 6 months Tigulixostat 200mg Tigulixostat Tigulixostat 200mg, Once a day (QD) for up to 6 months Tigulixostat 300mg Tigulixostat Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months Placebo Placebo Placebo, Once a day (QD) for up to 6 months
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
The proportion of subjects reporting a gout flare up to each visit. Up to Month 6 Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 6 months
Incidence rate of adverse event Up to Month 6 Safety assessment
Trial Locations
- Locations (50)
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
LTD "Clinic LJ"
🇬🇪Kutaisi, Georgia
Aleksandre Aladashvili Clinic LLC
🇬🇪Tbilisi, Georgia
LTD Israel-Georgian Medical Research Clinic Helsicore
🇬🇪Tbilisi, Georgia
JSC "Vian"
🇬🇪Tbilisi, Georgia
LTD MediClub Georgia
🇬🇪Tbilisi, Georgia
LTD Multiprofile Clinic Consilium Medulla
🇬🇪Tbilisi, Georgia
Angeles University Foundation Medical Center
🇵🇭Angeles, Philippines
Davao Doctors Hospital
🇵🇭Davao, Philippines
Lipa Medix Medical Center
🇵🇭Lipa, Philippines
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